CHAMGAP
MethodologyVerdictsExplanations (KO)Evidence CheckCitation KitMonitoring

LG2055 drinkable yogurt × Gaps in direct evidence for fewer cold infections

Select a review item to see its details.
Required evidence, verification status and materials actually read
ItemAVerification statusBReading scopeCReview itemDCurrent findingsEWhy unverifiedFRequired materials and conditionsGFurther research
1 Partly verified Full text not readStored summary read N01 · Scope and evidence gaps for infection incidence versus symptom-daysHow is the selected infection-incidence question distinguished from the symptom-day sheet?Required
The selected existing question is fewer cold infections. Its subclaim record is linked, while fewer days with questionnaire-recorded cold-like symptoms and the original parent context are preserved. No new question, subdivision or trial is created.
R01
Some original summary information was linked for production; clinical verification/review is incomplete. No new direct trial or clinical independence has been certified for the selected infection outcome.
Infection-incidence question and verdict linkage versus the parent and symptom-day endpoints
A prespecified research question distinguishing symptom-days from confirmed infection events
2 Partly verified Full text not readStored summary read N02 · Scope and evidence gaps for infection incidence versus symptom-daysWhat are the selected grade/note and the absent score, status and axes?Required
The selected ? grade and note that laboratory-confirmed infection incidence was not measured are preserved. The subclaim has no score, status or axes; parent C50 and its axes remain separate historical context.
R01
Some original summary information was linked for production; clinical verification/review is incomplete. The original subclaim lacks a score, status and axes.
Subclaim ? grade/note, absent score/status/axes and parent history
Separate preservation of the original grade from updates with additional evidence
3 Partly verified Full text not readStored summary read N03 · Scope and evidence gaps for infection incidence versus symptom-daysWho were the actual participants, and how was susceptibility to colds defined?Required
The original records 200 healthy Japanese adults aged 20–64 who were prone to colds. Specific eligibility definitions and medical or immune status are absent from the summary.
R01
Some original summary information was linked for production; clinical verification/review is incomplete. Cold susceptibility, baseline history, sex/severity and inclusion/exclusion criteria are unverified.
Recruitment of healthy Japanese adults aged 20–64 who were prone to colds
Research specifying the population and infection/symptom definitions
4 Partly verified Full text not readStored summary read N04 · Scope and evidence gaps for infection incidence versus symptom-daysWhat are the identities of the LG2055 study drink and strain?Required
The Korean text records drinkable yogurt containing LG2055; the English text and citation record Lactobacillus paragasseri SBT2055 (LG2055). This study drink and strain are distinguished from generic probiotic products.
R01
Some original summary information was linked for production; clinical verification/review is incomplete. Organism count, manufacture/storage, composition and actual product/quality specifications are unverified.
LG2055 drinkable yogurt and the original strain name
Research specifying the exact study drink and strain
5 Partly verified Full text not readStored summary read N05 · Scope and evidence gaps for infection incidence versus symptom-daysWhat were the control yogurt and comparison of interest?Required
The original active/control difference was the presence of LG2055; the control was identical yogurt with only LG2055 removed. The comparison was not no yogurt, no treatment or another product.
R01
Some original summary information was linked for production; clinical verification/review is incomplete. Equivalence/sensory properties, shared composition and actual exposure/adherence are unverified.
Identical yogurt with only LG2055 removed and the shared ingredients
Research specifying the contrast on an identical-yogurt background
6 Partly verified Full text not readStored summary read N06 · Scope and evidence gaps for infection incidence versus symptom-daysWhat were the intake amount, organism count, frequency and actual adherence?Required
The original gives LG2055 yogurt and 12 weeks of observation, but this summary lacks dose/drink volume, organism count, frequency and timing. The 198 intake completers and PPS do not establish actual daily exposure.
R01
Some original summary information was linked for production; clinical verification/review is incomplete. Amount/frequency, actual adherence, missed/contaminating exposure and storage conditions are unverified.
Target/actual study-drink exposure, adherence and deviations
A plan separating intended provision from actual exposure
7 Partly verified Full text not readStored summary read N07 · Scope and evidence gaps for infection incidence versus symptom-daysWhat were the 12-week winter observation, follow-up timing and longer-term scope?Required
The original observed questionnaire symptom-days for 12 weeks in winter. Infection-event follow-up, persistence after completion and direct results in other seasons or over longer periods are not separately provided.
R01
Some original summary information was linked for production; clinical verification/review is incomplete. Exact visit/observation windows, discontinuation/post-study observations and infection-event follow-up are unverified.
Winter observation, 12 weeks, time points and post-study outcomes
A plan distinguishing duration and symptom/infection outcomes
8 Unverified Full text not readStored summary read N08 · Scope and evidence gaps for infection incidence versus symptom-daysWas laboratory-confirmed infection incidence actually measured?Required
The original subclaim note and central explanation state that laboratory-confirmed infection incidence was not measured. Questionnaire symptom-days are not direct results for the selected infection events.
R01
The needed direct information was not verified within the current summary and unread-external-material scope. Pathogens/testing, confirmed events/denominators and direct comparative effects/CIs are unverified.
Pathogen-confirmed infection events and testing/diagnostic definitions
Research defining symptom questionnaires and confirmed infection events separately
9 Unverified Full text not readStored summary read N09 · Scope and evidence gaps for infection incidence versus symptom-daysWhat was the scope of clinician confirmation, pathogen types and testing times?Required
The original distinguishes questionnaire-recorded cold-like symptoms from laboratory-confirmed cold outcomes. Details of clinician-confirmed infections, pathogen types and test timing/diagnosis are not separately given.
R01
The needed direct information was not verified within the current summary and unread-external-material scope. Clinician adjudication, testing/pathogens, positivity criteria and event timing are unverified.
Clinician/test confirmation, pathogens/timing and the distinction from similar symptoms
Research defining confirmation methods, pathogens and observation times
10 Unverified Full text not readStored summary read N10 · Scope and evidence gaps for infection incidence versus symptom-daysAre there infected-person counts, first/recurrent events and incidence denominators?Required
The current summary supplies symptom-day aggregates. It lacks people infected at least once, first/recurrent infection events, confirmed-incidence numerators/denominators and follow-up.
R01
The needed direct information was not verified within the current summary and unread-external-material scope. Infected people/events, incidence, time/denominators and effects of interest/CIs are unverified.
People/events, time at risk, reinfections/repeats and denominators
Research distinguishing first/recurrent events and person/time denominators
11 Partly verified Full text not readStored summary read N11 · Scope and evidence gaps for infection incidence versus symptom-daysWhat units underlie the original runny-nose numerators, denominators and absolute difference?Supplementary
Original runny-nose days were 2,384/8,148 days (29.3%) versus 2,769/8,066 days (34.3%), with an absolute difference of −5.0 percentage points and P<0.001. These are preserved as aggregate symptom/observation days, not infection-event or person values.
R01
Some original summary information was linked for production; clinical verification/review is incomplete. Exact observation-day definitions, repeated/missing-data handling, denominator aggregation and CIs are unverified.
2,384/8,148 days versus 2,769/8,066 days, proportions and the original difference
A plan distinguishing estimands for people, observation days and symptom-days
12 Partly verified Full text not readStored summary read N12 · Scope and evidence gaps for infection incidence versus symptom-daysWhat do the other symptom proportions and cough P value mean?Supplementary
Original nasal-congestion 17.7/27.7%, sneezing 17.7/20.2%, sore-throat 6.3/12.2%, hoarseness 3.5/8.2% and cough P<0.001 are preserved. Each symptom is neither an infection-confirmation outcome nor an independent trial.
R01
Some original summary information was linked for production; clinical verification/review is incomplete. Symptom-specific numerators/denominators, CIs, definitions/hierarchy and multiplicity are unverified.
Original symptom-days for nasal congestion, sneezing, sore throat, hoarseness and cough
Research specifying symptom-specific outcomes and the planned hierarchy
13 Unverified Full text not readStored summary read N13 · Scope and evidence gaps for infection incidence versus symptom-daysWhat are the analysis units for people, observation days, symptoms and repeated records?Required
The 200 participants/PPS 193 and aggregate 8,148/8,066 observation days are different units. Multiple days or symptoms from the same person are not added as new independent participants or trials.
R01
The needed direct information was not verified within the current summary and unread-external-material scope. Within-person correlation, concurrent symptoms, aggregation/models and each person's observation duration are unverified.
Repeated diaries from the same people, symptoms/groups/times and correlation
Research distinguishing people, repeated records and events
14 Unverified Full text not readStored summary read N14 · Scope and evidence gaps for infection incidence versus symptom-daysAre questionnaire missingness, recording adherence and unmeasured infections distinguished?Required
The original supplies questionnaire symptom-days, PPS analysis and aggregate observation days, but lacks missing diaries/nonresponse, symptom handling and individual observation days. Unmeasured confirmed infection is a different gap from missing diaries.
R01
The needed direct information was not verified within the current summary and unread-external-material scope. Missingness/nonresponse, aggregation/imputation, individual day counts and infection data are unverified.
Missing diaries/symptoms, unmeasured infections and imputation/denominators
A plan distinguishing missing records from unmeasured infection events
15 Partly verified Full text not readStored summary read N15 · Scope and evidence gaps for infection incidence versus symptom-daysWhat were the prespecified primary, symptom-specific/secondary and composite outcomes and multiplicity rules?Required
The original describes questionnaire symptom-days as primary and states that multiple symptoms were not tested as a single prespecified hierarchical composite score. External plans for individual, secondary/exploratory outcomes and multiplicity were not read.
R01
Some original summary information was linked for production; clinical verification/review is incomplete. Prespecified lists/hierarchy, multiplicity, success criteria and secondary analyses are unverified.
Original primary symptom-days, hierarchical composite and secondary hierarchy
Research prespecifying symptom/infection and primary/secondary estimands
16 Partly verified Full text not readStored summary read N16 · Scope and evidence gaps for infection incidence versus symptom-daysWhat was the original discrepancy between the registry ID, claimed preregistration and public date?Required
The original says the paper claimed registration before study start, but the UMIN public date 2022-09-08 followed the planned start 2021-10-30, making registration retrospective by the public record. This historical discrepancy is preserved; the external registry was not newly verified.
R01
Some original summary information was linked for production; clinical verification/review is incomplete. Actual registry versions, amendment/public/start details and original prespecified plans remain unread.
UMIN000045901, original planned-start/public dates and unread external records
Records separating plans from publication/amendment events
17 Partly verified Full text not readStored summary read N17 · Scope and evidence gaps for infection incidence versus symptom-daysWhat were the actual randomization, identical-yogurt and double-blinding procedures?Required
The original design is a double-blind randomized identical-yogurt placebo-controlled parallel trial. The summary lacks sequence/concealment, who was blinded, equivalence and awareness-of-condition details.
R01
Some original summary information was linked for production; clinical verification/review is incomplete. Allocation/concealment, baseline balance and blinding/sensory/awareness procedures are unverified.
Allocation/concealment, baseline balance, blinding and awareness of conditions
An allocation/blinding plan for identical yogurt
18 Partly verified Full text not readStored summary read N18 · Scope and evidence gaps for infection incidence versus symptom-daysWhat were the original randomized, intake-completer, exclusion and PPS counts?Required
The original 200 randomized, 100 assigned per arm, 198 intake completers, 5 exclusions and PPS primary-efficacy population of 193 (97/96) are preserved. Detailed arm-specific flow and endpoint observations are absent.
R01
Some original summary information was linked for production; clinical verification/review is incomplete. Arm-specific completion/exclusion reasons, detailed PPS 97/96 mapping and endpoint denominators are unverified.
200, 100 per arm, 198 completers, original 5 exclusions and 193 (97/96)
A plan distinguishing randomized, completer and analysis populations
19 Partly verified Full text not readStored summary read N19 · Scope and evidence gaps for infection incidence versus symptom-daysWhat were the PPS, completer, ITT and other analysis populations and missing-data handling?Required
Original primary efficacy concerns 193 per-protocol completers, not all 200 randomized participants. All-randomized/ITT analysis, imputation, sensitivity and adherence-effect details are not supplied.
R01
Some original summary information was linked for production; clinical verification/review is incomplete. PPS selection, analysis models, ITT/imputation, sensitivity and missingness/attrition reasons are unverified.
Original primary-efficacy PPS versus the estimand for all randomized participants
Research prespecifying assignment/adherence effects and missingness
20 Unverified Full text not readStored summary read N20 · Scope and evidence gaps for infection incidence versus symptom-daysWere baseline infection risk and shared lifestyle/treatment exposures verified?Required
The original supplies healthy adults prone to colds, identical yogurt and winter context. Detailed arm-specific baseline infection risk, concurrent drugs/lifestyle and exposure/environment are absent.
R01
The needed direct information was not verified within the current summary and unread-external-material scope. Baseline/changed medication, lifestyle/infection exposure, shared support and arm differences are unverified.
Cold susceptibility, concurrent exposures/drugs, arm-specific risk and shared conditions
Research specifying shared conditions and infection risk
21 Partly verified Full text not readStored summary read N21 · Scope and evidence gaps for infection incidence versus symptom-daysHow were subjective questionnaires collected and adjudicated?Required
The endpoint is days with questionnaire-recorded cold-like symptoms. Symptom criteria, recording frequency/severity, assessment/adjudication and links to testing are not detailed.
R01
Some original summary information was linked for production; clinical verification/review is incomplete. Diary/assessment methods, symptom thresholds, confirmation/classification and severity procedures are unverified.
Diaries, symptom definitions/severity and assessors versus testing
A measurement plan separating subjective symptoms from confirmed infection
22 Partly verified Full text not readStored summary read N22 · Scope and evidence gaps for infection incidence versus symptom-daysWhat were the original unreported CIs, precision and missing direct infection estimates?Required
The original states that between-group 95% CIs for symptom-days were not provided. Effects/CIs for the selected confirmed-infection incidence are also unavailable. This run did not newly review nonreporting in the external paper.
R01
Some original summary information was linked for production; clinical verification/review is incomplete. Symptom-day models/intervals, repeated correlation, direct infection effects/intervals and clinical importance are unverified.
Original symptom-day −5.0 percentage points/P, absent 95% CI and the infection-estimate gap
Research specifying units, estimands and precision
23 Partly verified Full text not readStored summary read N23 · Scope and evidence gaps for infection incidence versus symptom-daysAre within/between-group symptom-days, periods and event estimands distinguished?Required
The original gives 12-week aggregates of days with symptoms and between-group proportion differences. Individual symptom-day changes, adjustments/models and confirmed-infection event contrasts are not separately detailed.
R01
Some original summary information was linked for production; clinical verification/review is incomplete. Individual/period-specific data, baseline/adjustment, estimands and infection-event definitions are unverified.
Original day-proportion contrast versus individuals/infection, adjustment and models
Research separating symptom-days, people/events and within/between-group contrasts
24 Partly verified Full text not readStored summary read N24 · Scope and evidence gaps for infection incidence versus symptom-daysWhat were the original sponsor, employee/contractor and product-development details?Required
The original describes EK, TA, MK and TK as MEGMILK SNOW BRAND employees, NS as a KSO Corporation employee and LG2055 drinkable yogurt as company-developed. Its statement that separate public cofunding, medical writing and publication-cost support were not identified is also preserved.
R01
Some original summary information was linked for production; clinical verification/review is incomplete. Current details of original disclosures/support and design/analysis/data-access roles remain unread.
Four MEGMILK employees, a KSO employee and product/support scope
Explicit support and research-decision/analysis roles
25 Partly verified Full text not readStored summary read N25 · Scope and evidence gaps for infection incidence versus symptom-daysAre reports/trials, symptoms/person-days and sibling sheets linked to the same family?Required
The single current evidence/citation entry for Kobatake 2022 is linked as one report slot. People, arms, days, symptoms, times and sibling sheets share the original context; they are not new independent trials or participants to be added.
R01
Some original summary information was linked for production; clinical verification/review is incomplete. Related report/trial relationships and unique trial/participant totals are unverified.
Kobatake 2022 citation and relationships within the same population/observations
Records distinguishing reports from study families
26 Unverified Full text not readStored summary read N26 · Scope and evidence gaps for infection incidence versus symptom-daysIs there direct replication or independent confirmation for confirmed infection?Required
Parent R1/I0 and the single manufacturer-program trial are historical symptom-day context. Direct original data for independent replication of the selected confirmed-infection outcome were not searched for or acquired in this run.
R01
The needed direct information was not verified within the current summary and unread-external-material scope. Direct confirmed-infection reports, populations/strains/testing and overlap/independence are unverified.
Direct trials of the selected infection incidence, confirmation methods and identities
Separate research defining confirmed-infection events
27 Partly verified Full text not readStored summary read N27 · Scope and evidence gaps for infection incidence versus symptom-daysWhat is the applicability to other products/strains, populations and settings?Supplementary
The original concerns symptom-days in healthy Japanese adults aged 20–64 during winter using LG2055 and identical yogurt. Confirmed-infection effects for other strains/products, populations or seasons are not given.
R01
Some original summary information was linked for production; clinical verification/review is incomplete. Direct effects, CIs and interactions by population, strain, product and setting are unverified.
Original LG2055 identical-yogurt/winter-adult context versus other scopes
Research prespecifying direct applicability
28 Partly verified Full text not readStored summary read N28 · Scope and evidence gaps for infection incidence versus symptom-daysAre fewer symptom-days distinguished from infection prevention and important clinical outcomes?Supplementary
The original summary and central explanation state that fewer symptom-days do not establish prevention of cold infections themselves. Direct values for immunity, clinical visits/hospitalization and serious infection are also absent.
R01
Some original summary information was linked for production; clinical verification/review is incomplete. Direct infection and patient-important/clinical events, effects, denominators and CIs are unverified.
Questionnaire symptoms, confirmed infection and immune/serious clinical outcomes
A plan separating symptom questions from confirmed-infection/clinical questions
29 Partly verified Full text not readStored summary read N29 · Scope and evidence gaps for infection incidence versus symptom-daysWhat are persistence, repeated-use or prevention effects beyond 12 weeks?Supplementary
The original observation concerns 12-week symptom-days. Persistence after discontinuation, repeated/longer use and long-term confirmed-infection outcomes are absent.
R01
Some original summary information was linked for production; clinical verification/review is incomplete. Direct post-study/long-term benefits/harms, denominators and CIs are unverified.
Exposure duration, after discontinuation and other/long-term infection outcomes
Research distinguishing persistence/repetition questions from infection events
30 Partly verified Full text not readStored summary read N30 · Scope and evidence gaps for infection incidence versus symptom-daysWhat was read in the summary, what remains externally unread, and what do source links mean?Required
The complete preserved 2977 summary was read and saved for production. Original PubMed and UMIN references are source connections; external content/link access, clicking and testing were not performed in that production.
R01
Some original summary information was linked for production; clinical verification/review is incomplete. Current external-method/result and registry/planning details remain unverified.
Complete existing review summary, abstract/full text/registry and needed materials
Records separating summary preservation from newly acquired materials
31 Partly verified Full text not readStored summary read N31 · Scope and evidence gaps for infection incidence versus symptom-daysWhat are the original bilingual text, dates/corrections, axes, absences and history?Required
Bilingual text, the original date 2026-08-26 and empty correction/deliberation records are preserved. Parent C50, B/P/R1/I0/E+/B1, unrecorded precision, three false flags and empty grade-override reasons are historical; separate classification and primary-failure/secondary-positive fields are absent.
R01
Some original summary information was linked for production; clinical verification/review is incomplete. External detailed translation, registry/original-text and correction comparisons were not performed in this run.
Languages, dates, empty values, parent C50/axes and original verdict narrative
Separate original values/absences from new updates
32 Partly verified Full text not readStored summary read N32 · Scope and evidence gaps for infection incidence versus symptom-daysWhat was the original scope of adverse-event collection and related serious safety signals?Supplementary
The original records no reported serious safety signal related to the test food in the 12-week trial. Collection methods/definitions, all events and relatedness-adjudication tables are absent.
R01
Some original summary information was linked for production; clinical verification/review is incomplete. Harm collection, all/serious events, relatedness and discontinuation tables are unverified.
Collection/definitions, all events, severity and relatedness
Research specifying harm collection separately from efficacy
33 Partly verified Full text not readStored summary read N33 · Scope and evidence gaps for infection incidence versus symptom-daysAre dairy allergy and lactose discomfort actual trial events?Supplementary
The original mentions dairy allergy and lactose-related discomfort in the product-ingredient context. This is not a count or causal result showing those events occurred in this trial.
R01
Some original summary information was linked for production; clinical verification/review is incomplete. Population selection, actual events/denominators, severity and relatedness are unverified.
Original cautionary context versus the relevant population/events
Research specifying safety questions for vulnerable populations
34 Unverified Full text not readStored summary read N34 · Scope and evidence gaps for infection incidence versus symptom-daysWere arm-specific harms, collection populations/denominators and effects verified?Supplementary
It is unverified whether randomized/completer/PPS populations match the harm-collection population. The summary lacks arm-specific harm events/denominators, comparisons and CIs.
R01
The needed direct information was not verified within the current summary and unread-external-material scope. Arm/period-specific collection, events/exposure denominators and comparative effects/CIs are unverified.
200/198/PPS 193 versus separate harm denominators/comparisons
Research distinguishing efficacy populations from harm-collection populations
35 Unverified Full text not readStored summary read N35 · Scope and evidence gaps for infection incidence versus symptom-daysWhat were harm timing and post-study/delayed follow-up?Supplementary
The original has a 12-week safety narrative but no separate event timing, period-specific observation or post-study/delayed-harm data.
R01
The needed direct information was not verified within the current summary and unread-external-material scope. Event timing, post-discontinuation/long-term observation and exposure changes are unverified.
12-week exposure, event/follow-up times and longer-term scope
Research distinguishing timing and delayed harms
36 Unverified Full text not readStored summary read N36 · Scope and evidence gaps for infection incidence versus symptom-daysHow do shared yogurt, baseline/infection exposures and harm relatedness connect?Supplementary
The original compares identical yogurt with and without LG2055. Actual adjudication attributing harms/similar symptoms to the strain, shared drink, infection or other causes is absent.
R01
The needed direct information was not verified within the current summary and unread-external-material scope. Medical history/drugs, exposures, actual events/relatedness and alternative causes are unverified.
LG2055/shared ingredients, concurrent drugs/illnesses and alternative causes
A plan distinguishing the exposure of interest from alternative causes
37 Unverified Full text not readStored summary read N37 · Scope and evidence gaps for infection incidence versus symptom-daysAre completion/exclusion and missing diaries distinguished from harm-related discontinuation?Supplementary
Original completion/exclusion counts are preserved, but harm/protocol/diary reasons and harm collection in omitted participants are not detailed.
R01
The needed direct information was not verified within the current summary and unread-external-material scope. Arm-specific exclusions/discontinuations/missingness, their harm relationships and collection/handling are unverified.
Original 198 completers/5 exclusions, PPS and harm/missingness reasons
A plan separating missingness from harm-related discontinuation
38 Unverified Full text not readStored summary read N38 · Scope and evidence gaps for infection incidence versus symptom-daysHow are independent harm data distinguished from observations in the same trial?Supplementary
The current listing is this symptom-day efficacy report. Separate original harm data were not searched for or acquired in this run; the same report, arms, person-days and siblings are not counted as independent harm trials.
R01
The needed direct information was not verified within the current summary and unread-external-material scope. Independent harm-report identities, populations/exposures and overlap are unverified.
Separate safety-report identities, exposures/populations and overlap
Independent safety research with clear populations/exposures
39 Unverified Full text not readStored summary read N39 · Scope and evidence gaps for infection incidence versus symptom-daysWhat is known about vulnerable populations, other illnesses/products and repeated/long-term safety?Supplementary
A 12-week drink study in healthy adults cannot establish safety for other illnesses/ages, immune states, products or repeated/long-term exposures.
R01
The needed direct information was not verified within the current summary and unread-external-material scope. Vulnerable populations/concurrent medication, direct events and long-term/repeated-exposure data are unverified.
Healthy adults versus allergy/illness and long-term scope
Research separating population and long-term safety questions
40 Partly verified Full text not readStored summary read N40 · Scope and evidence gaps for infection incidence versus symptom-daysAre the causal scopes of symptom-day benefit, infection gaps and the original good safety status distinguished?Supplementary
Fewer symptom-days, unmeasured laboratory-confirmed infections, no reported serious related signals and the parent's good safety status are preserved separately. Symptom-day benefit does not certify infection prevention, improved immunity or safety.
R01
Some original summary information was linked for production; clinical verification/review is incomplete. Direct confirmed-infection/comparative-harm data, causality and long-term precision are unverified.
Different benefits/events, original safety and harm causality
A plan separating different outcomes and estimands
41 Partly verified Full text not readStored summary read N41 · Scope and evidence gaps for infection incidence versus symptom-daysHow are follow-up materials, historical candidates/versions and incomplete prior content review connected?Supplementary
Criteria are saved and frozen before separate application. Prior candidate pending/eligible states remain history. Current content/boundary review is incomplete; completion is false, new units are 0 and final independent counts remain unrecorded.
R01
Some original summary information was linked for production; clinical verification/review is incomplete. No follow-up original materials, actual reading, changes or content-review/independence decisions yet exist.
Review summary/criteria, original values/units, new materials and user decisions
Research addressing direct gaps in confirmed-infection incidence
No items match your search or filter.

41 itemsWhat the statuses mean

Assessment scope

Stored-material review date
Not recorded
Original evidence cut-off
2026-08-26
Scope actually checked
Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean
This is the date the stored materials were checked, not the date of a new search of the clinical literature.
Population
Original context: 200 healthy Japanese adults aged 20–64 who were prone to colds; PPS 193 (97/96). Direct confirmed-infection analysis population/denominators are unverified.
Ingredient, formulation and route
Drinkable yogurt containing Lactobacillus paragasseri SBT2055 (LG2055)
Dose
Original drink volume, organism count and intake frequency are unspecified; direct confirmed-infection study exposure is unverified. No intake/conversion instructions.
Comparator
Symptom-day context comparing identical yogurt with only LG2055 removed; a direct confirmed-infection comparison is unverified.
Measured outcome
Selected cold-infection incidence: test/clinician confirmation, pathogens, people/events and denominators are unverified; distinguished from original questionnaire symptom-days.
Duration
Original 12-week winter symptom-day observation; direct confirmed-infection and long-term follow-up are unverified.
Questions outside this scope
Transferring symptom-day/sibling benefits into direct effects on test/clinician-confirmed infection incidence; Converting observation days, symptom proportions or original differences into infected people/events, infection risk differences, RR or NNT; Adding the same people, arms, person-days, symptoms, times, citation or sibling sheets as independent trials/participants; Extending the LG2055 drink to all probiotics/products, immunity/infection prevention or long-term safety; Instructions for probiotic/drink/product intake, cold management/infection prevention or treatment substitution

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

R01 · Kobatake E, et al. Intake of Lactobacillus paragasseri SBT2055 improves subjective symptoms of common cold during winter season in healthy adults. Front Nutr. 2022;9:1063584. PMID: 36570128.

PubMed

Material type
Kobatake 2022 LG2055 yogurt questionnaire symptom-day contextual report; not a direct confirmed-infection trial
Materials actually read
Summary read; external materials unread, access not attempted
Findings recorded in the stored summary
Runny nose 29.3% versus 34.3%, absolute difference −5.0 percentage points, P<0.001; 95% CI not reported
Record level
Contextual symptom-day 29.3/34.3%, original −5.0 percentage points/P<.001; not confirmed-infection person/event/incidence results. The original states no 95% CI was reported; repetition, denominators and model details are unverified.
Study overlap and independent replication
The same Kobatake 2022 trial/citation links both identical-yogurt arms, randomized/completer/PPS populations, symptoms/repeated days and parent/sibling sheets. These are not added as new direct confirmed-infection trials or independent participants.
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
Stored summaryLocal preserved summarySummary readSummary readOnly acquisition/reading of the complete parent summary is established, not original confirmed-infection research, paper or registry acquisition.
AbstractExternal materials unread/neededUnread; access not attemptedNot readOnly the original citation link is connected. External access, content verification and link testing were not attempted.
Full paperExternal materials unread/neededUnread; access not attemptedNot readThe original bibliography supplies no DOI/PMCID. No original full text or external content was newly acquired/read.
Registration materialExternal materials unread/neededUnread; access not attemptedNot readOriginal UMIN000045901 and historical public/planned-start narrative are preserved. It is not NCT. External versions/content remain unread.
ProtocolExternal materials unread/neededUnread; access not attemptedNot readOriginal plans for identical yogurt/exposure, questionnaire/infection definitions, primary/secondary outcomes and harms are needed. Public availability/existence is unverified.
Statistical analysis planExternal materials unread/neededUnread; access not attemptedNot readOriginal plans for PPS/randomization, people/observation days, repetition/missingness, symptoms/composites and multiplicity are needed.
Outcome tables and questionnaire-day/infection/denominator/harm dataExternal materials unread/neededUnread; access not attemptedNot readSymptom-day records/denominators, arm-specific PPS/flow and detailed harms are needed. Confirmed infection was originally unmeasured; separate direct data are needed.
Funding/conflict-of-interest disclosuresExternal materials unread/neededUnread; access not attemptedNot readOriginal disclosures on company development/employees, KSO contracting and support roles remain unread.

Report counts versus independent study counts

The same Kobatake 2022 trial/citation links both identical-yogurt arms, randomized/completer/PPS populations, symptoms/repeated days and parent/sibling sheets. These are not added as new direct confirmed-infection trials or independent participants.

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · How is the selected infection-incidence question distinguished from the symptom-day sheet?
Required materials and conditions
Infection-incidence question and verdict linkage versus the parent and symptom-day endpoints
Conditions for verification
Separate original information about Infection-incidence question and verdict linkage versus the parent and symptom-day endpoints from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Requirement and applicability
Required
Application exceptions
Do not transfer the sibling C grade or positive symptom-day findings into direct evidence or a grade for infection incidence.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: How is the selected infection-incidence question distinguished from the symptom-day sheet?
Referenced methods
Question-clarification principles in M03 §3.1, §3.2.1–3.2.4; Detailed separation rules are internally designed; M03 §3.2.4; Internally defined extrapolation boundaries; Distinguishing studies from reports in M04 §4.6.1–4.6.2; Cohort/outcome linkage is an internal application
N02 · What are the selected grade/note and the absent score, status and axes?
Required materials and conditions
Subclaim ? grade/note, absent score/status/axes and parent history
Conditions for verification
Separate original information about Subclaim ? grade/note, absent score/status/axes and parent history from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Requirement and applicability
Required
Application exceptions
Do not fill subclaim values or claim a current review pass using the parent score of 50 or symptom-endpoint P/E+ axes.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: What are the selected grade/note and the absent score, status and axes?
Referenced methods
M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design
N03 · Who were the actual participants, and how was susceptibility to colds defined?
Required materials and conditions
Recruitment of healthy Japanese adults aged 20–64 who were prone to colds
Conditions for verification
Separate original information about Recruitment of healthy Japanese adults aged 20–64 who were prone to colds from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Requirement and applicability
Required
Application exceptions
Do not extend healthy-adult findings to infection prevention for all ages, illnesses or immunocompromised people.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: Who were the actual participants, and how was susceptibility to colds defined?
Referenced methods
M03 §3.2.1; detailed population conditions are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application
N04 · What are the identities of the LG2055 study drink and strain?
Required materials and conditions
LG2055 drinkable yogurt and the original strain name
Conditions for verification
Separate original information about LG2055 drinkable yogurt and the original strain name from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Requirement and applicability
Required
Application exceptions
Do not generalize an isolated effect to generic probiotics or other strains/products, or arbitrarily rename the strain.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: What are the identities of the LG2055 study drink and strain?
Referenced methods
M03 §§3.2.2–3.2.3; reverse-direction labels and assessment adaptation are Chamgap-designed; M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed
N05 · What were the control yogurt and comparison of interest?
Required materials and conditions
Identical yogurt with only LG2055 removed and the shared ingredients
Conditions for verification
Separate original information about Identical yogurt with only LG2055 removed and the shared ingredients from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Requirement and applicability
Required
Application exceptions
Do not transfer symptom-day results into infection prevention by yogurt as a whole or an isolated LG2055 effect on confirmed infections.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: What were the control yogurt and comparison of interest?
Referenced methods
M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application
N06 · What were the intake amount, organism count, frequency and actual adherence?
Required materials and conditions
Target/actual study-drink exposure, adherence and deviations
Conditions for verification
Separate original information about Target/actual study-drink exposure, adherence and deviations from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Requirement and applicability
Required
Application exceptions
Do not create intake amounts, dosing instructions or organism-count conversions for probiotics, drinks or products.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: What were the intake amount, organism count, frequency and actual adherence?
Referenced methods
M03 §3.2.2–3.2.3; Reverse-direction labeling and test adaptations are internally designed; M08 §8.2.2, M15 §15.3.1; Internal application; M03 §3.2.1–3.2.4; Dose, persistence and effect-modification details are internally designed
N07 · What were the 12-week winter observation, follow-up timing and longer-term scope?
Required materials and conditions
Winter observation, 12 weeks, time points and post-study outcomes
Conditions for verification
Separate original information about Winter observation, 12 weeks, time points and post-study outcomes from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Requirement and applicability
Required
Application exceptions
Do not turn 12-week symptom observation into continuous infection prevention or effects across an entire season or the long term.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: What were the 12-week winter observation, follow-up timing and longer-term scope?
Referenced methods
M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed
N08 · Was laboratory-confirmed infection incidence actually measured?
Required materials and conditions
Pathogen-confirmed infection events and testing/diagnostic definitions
Conditions for verification
Separate original information about Pathogen-confirmed infection events and testing/diagnostic definitions from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Requirement and applicability
Required
Application exceptions
Preserve the original statement of nonmeasurement without newly judging infection incidence or effects as zero, or prevention as successful.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: Was laboratory-confirmed infection incidence actually measured?
Referenced methods
M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 Table 8.2.a and M03 §3.2.4; Chamgap application; M03 §3.2.4; Chamgap interpretation boundary
N09 · What was the scope of clinician confirmation, pathogen types and testing times?
Required materials and conditions
Clinician/test confirmation, pathogens/timing and the distinction from similar symptoms
Conditions for verification
Separate original information about Clinician/test confirmation, pathogens/timing and the distinction from similar symptoms from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Requirement and applicability
Required
Application exceptions
Do not invent clinician adjudication or testing absent from the summary, or attribute symptoms to a particular infection.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: What was the scope of clinician confirmation, pathogen types and testing times?
Referenced methods
M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 Table 8.2.a and M03 §3.2.4; Chamgap application; M03 §3.2.4; Chamgap interpretation boundary
N10 · Are there infected-person counts, first/recurrent events and incidence denominators?
Required materials and conditions
People/events, time at risk, reinfections/repeats and denominators
Conditions for verification
Separate original information about People/events, time at risk, reinfections/repeats and denominators from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Requirement and applicability
Required
Application exceptions
Do not convert symptom-day proportions into proportions of infected people, infection-event counts or incidence.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: Are there infected-person counts, first/recurrent events and incidence denominators?
Referenced methods
M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are internally designed; M08 §8.2.2, M15 §15.3.1; Internal application; M03 §3.2.4; Internally defined extrapolation boundaries
N11 · What units underlie the original runny-nose numerators, denominators and absolute difference?
Required materials and conditions
2,384/8,148 days versus 2,769/8,066 days, proportions and the original difference
Conditions for verification
Separate original information about 2,384/8,148 days versus 2,769/8,066 days, proportions and the original difference from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Requirement and applicability
Supplementary
Application exceptions
Do not recalculate the original −5.0 percentage points or convert it into infection risk differences, RR/NNT or individual prevention probabilities.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: What units underlie the original runny-nose numerators, denominators and absolute difference?
Referenced methods
M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application
N12 · What do the other symptom proportions and cough P value mean?
Required materials and conditions
Original symptom-days for nasal congestion, sneezing, sore throat, hoarseness and cough
Conditions for verification
Separate original information about Original symptom-days for nasal congestion, sneezing, sore throat, hoarseness and cough from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Requirement and applicability
Supplementary
Application exceptions
Do not combine symptoms or time points into new confirmed-infection counts or a composite success score.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: What do the other symptom proportions and cough P value mean?
Referenced methods
M04 §4.6.3, M15 §15.3.1–15.3.3; Status separation is internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M04 §4.6.3; Internal application; M03 §3.2.4; Internally defined extrapolation boundaries
N13 · What are the analysis units for people, observation days, symptoms and repeated records?
Required materials and conditions
Repeated diaries from the same people, symptoms/groups/times and correlation
Conditions for verification
Separate original information about Repeated diaries from the same people, symptoms/groups/times and correlation from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Requirement and applicability
Required
Application exceptions
Do not reanalyze all observation days as independent binary observations or inflate the sample size.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: What are the analysis units for people, observation days, symptoms and repeated records?
Referenced methods
Distinguishing studies from reports in M04 §4.6.1–4.6.2; Cohort/outcome linkage is an internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are internally designed; M08 Table 8.2.a, M03 §3.2.4; Internal application; M08 §8.2.2, M15 §15.3.1; Internal application
N14 · Are questionnaire missingness, recording adherence and unmeasured infections distinguished?
Required materials and conditions
Missing diaries/symptoms, unmeasured infections and imputation/denominators
Conditions for verification
Separate original information about Missing diaries/symptoms, unmeasured infections and imputation/denominators from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Requirement and applicability
Required
Application exceptions
Do not fill missing days as symptom-free/infection-free or treat unmeasured infection as a zero effect.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: Are questionnaire missingness, recording adherence and unmeasured infections distinguished?
Referenced methods
M08 Table 8.2.a, M03 §3.2.4; Internal application; M08 §8.2.2, M15 §15.3.1; Internal application; M08 Table 8.2.a, M04 §4.6.3; Internal application
N15 · What were the prespecified primary, symptom-specific/secondary and composite outcomes and multiplicity rules?
Required materials and conditions
Original primary symptom-days, hierarchical composite and secondary hierarchy
Conditions for verification
Separate original information about Original primary symptom-days, hierarchical composite and secondary hierarchy from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Requirement and applicability
Required
Application exceptions
Do not establish overall infection-prevention efficacy or a new composite outcome from one selected positive symptom.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: What were the prespecified primary, symptom-specific/secondary and composite outcomes and multiplicity rules?
Referenced methods
M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap design; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap design
N16 · What was the original discrepancy between the registry ID, claimed preregistration and public date?
Required materials and conditions
UMIN000045901, original planned-start/public dates and unread external records
Conditions for verification
Separate original information about UMIN000045901, original planned-start/public dates and unread external records from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Requirement and applicability
Required
Application exceptions
Do not replace UMIN with NCT, calculate the date gap or upgrade it to a current registry-review pass.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: What was the original discrepancy between the registry ID, claimed preregistration and public date?
Referenced methods
M08 Table 8.2.a, M04 §4.6.3; Internal application; M04 §4.5, §4.6.3; Current conversion limits follow the review scope and internal design; Collection/selection principles in M04 §4.5–4.6; Separating access from reading and the hyperlink contract are internally designed
N17 · What were the actual randomization, identical-yogurt and double-blinding procedures?
Required materials and conditions
Allocation/concealment, baseline balance, blinding and awareness of conditions
Conditions for verification
Separate original information about Allocation/concealment, baseline balance, blinding and awareness of conditions from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Requirement and applicability
Required
Application exceptions
Do not certify successful blinding, absence of bias or independence from the original design label or B1 axis.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: What were the actual randomization, identical-yogurt and double-blinding procedures?
Referenced methods
M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application
N18 · What were the original randomized, intake-completer, exclusion and PPS counts?
Required materials and conditions
200, 100 per arm, 198 completers, original 5 exclusions and 193 (97/96)
Conditions for verification
Separate original information about 200, 100 per arm, 198 completers, original 5 exclusions and 193 (97/96) from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Requirement and applicability
Required
Application exceptions
Do not calculate or add new dropout/exclusion counts or proportions from 200/198/193.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: What were the original randomized, intake-completer, exclusion and PPS counts?
Referenced methods
M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application
N19 · What were the PPS, completer, ITT and other analysis populations and missing-data handling?
Required materials and conditions
Original primary-efficacy PPS versus the estimand for all randomized participants
Conditions for verification
Separate original information about Original primary-efficacy PPS versus the estimand for all randomized participants from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Requirement and applicability
Required
Application exceptions
Do not replicate symptom-day PPS findings as direct effects for all randomized people or confirmed-infection populations.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: What were the PPS, completer, ITT and other analysis populations and missing-data handling?
Referenced methods
M08 §8.2.2, M15 §15.3.1; Internal application; M08 Table 8.2.a, M04 §4.6.3; Internal application
N20 · Were baseline infection risk and shared lifestyle/treatment exposures verified?
Required materials and conditions
Cold susceptibility, concurrent exposures/drugs, arm-specific risk and shared conditions
Conditions for verification
Separate original information about Cold susceptibility, concurrent exposures/drugs, arm-specific risk and shared conditions from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Requirement and applicability
Required
Application exceptions
Do not add infection-prevention/treatment components absent from the original as actual trial exposures or instructions.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: Were baseline infection risk and shared lifestyle/treatment exposures verified?
Referenced methods
M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M03 §3.2.1; detailed population conditions are internally designed; M19 §19.2.2–19.2.4 design considerations; detailed confounding records are internally designed
N21 · How were subjective questionnaires collected and adjudicated?
Required materials and conditions
Diaries, symptom definitions/severity and assessors versus testing
Conditions for verification
Separate original information about Diaries, symptom definitions/severity and assessors versus testing from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Requirement and applicability
Required
Application exceptions
Do not automatically classify symptomatic colds as clinician/test-confirmed diagnoses.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: How were subjective questionnaires collected and adjudicated?
Referenced methods
M08 Table 8.2.a, M03 §3.2.4; own application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific result adaptation is our own design
N22 · What were the original unreported CIs, precision and missing direct infection estimates?
Required materials and conditions
Original symptom-day −5.0 percentage points/P, absent 95% CI and the infection-estimate gap
Conditions for verification
Separate original information about Original symptom-day −5.0 percentage points/P, absent 95% CI and the infection-estimate gap from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Requirement and applicability
Required
Application exceptions
Do not calculate new CI/RR/NNT from aggregate days or transfer them into infection-effect estimates.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: What were the original unreported CIs, precision and missing direct infection estimates?
Referenced methods
M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are internally designed; M15 §15.3.1–15.3.3; Internal application; M04 §4.5, §4.6.3; Current conversion limits follow the review scope and internal design
N23 · Are within/between-group symptom-days, periods and event estimands distinguished?
Required materials and conditions
Original day-proportion contrast versus individuals/infection, adjustment and models
Conditions for verification
Separate original information about Original day-proportion contrast versus individuals/infection, adjustment and models from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Requirement and applicability
Required
Application exceptions
Do not interpret aggregate proportions as reduced individual infection risk or guaranteed prevention.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: Are within/between-group symptom-days, periods and event estimands distinguished?
Referenced methods
M08 §8.2.2, M15 §15.3.1; Internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are internally designed; M03 §3.2.4; Internally defined extrapolation boundaries
N24 · What were the original sponsor, employee/contractor and product-development details?
Required materials and conditions
Four MEGMILK employees, a KSO employee and product/support scope
Conditions for verification
Separate original information about Four MEGMILK employees, a KSO employee and product/support scope from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Requirement and applicability
Required
Application exceptions
Do not add the contractor employee to the four company employees or regrade original values solely because of sponsorship.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: What were the original sponsor, employee/contractor and product-development details?
Referenced methods
Chamgap’s own independence/attribution conditions. The official methodological sections used in this pilot do not guarantee every detailed item; M08 §8.1–8.2.3; internal application
N25 · Are reports/trials, symptoms/person-days and sibling sheets linked to the same family?
Required materials and conditions
Kobatake 2022 citation and relationships within the same population/observations
Conditions for verification
Separate original information about Kobatake 2022 citation and relationships within the same population/observations from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Requirement and applicability
Required
Application exceptions
One report slot does not certify one direct confirmed-infection trial or a final clinically independent count.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: Are reports/trials, symptoms/person-days and sibling sheets linked to the same family?
Referenced methods
Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application
N26 · Is there direct replication or independent confirmation for confirmed infection?
Required materials and conditions
Direct trials of the selected infection incidence, confirmation methods and identities
Conditions for verification
Separate original information about Direct trials of the selected infection incidence, confirmation methods and identities from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Requirement and applicability
Required
Application exceptions
Do not count sibling symptom reports as independent infection trials or extend the original single trial into a current worldwide absence-of-research finding.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: Is there direct replication or independent confirmation for confirmed infection?
Referenced methods
Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application
N27 · What is the applicability to other products/strains, populations and settings?
Required materials and conditions
Original LG2055 identical-yogurt/winter-adult context versus other scopes
Conditions for verification
Separate original information about Original LG2055 identical-yogurt/winter-adult context versus other scopes from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Requirement and applicability
Supplementary
Application exceptions
Do not extend findings into general immune improvement, prevention of all infections, product recommendations or intake instructions.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: What is the applicability to other products/strains, populations and settings?
Referenced methods
M03 §3.2.1; Detailed population conditions are internally designed; M03 §3.2.2–3.2.3; Reverse-direction labeling and test adaptations are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; Internal application; M03 §3.2.1–3.2.4; Dose, persistence and effect-modification details are internally designed
N28 · Are fewer symptom-days distinguished from infection prevention and important clinical outcomes?
Required materials and conditions
Questionnaire symptoms, confirmed infection and immune/serious clinical outcomes
Conditions for verification
Separate original information about Questionnaire symptoms, confirmed infection and immune/serious clinical outcomes from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Requirement and applicability
Supplementary
Application exceptions
Do not turn positive symptom-day findings into laboratory-confirmed prevention, improved immunity or treatment substitution.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: Are fewer symptom-days distinguished from infection prevention and important clinical outcomes?
Referenced methods
M03 §3.2.4; internally defined extension boundary; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed
N29 · What are persistence, repeated-use or prevention effects beyond 12 weeks?
Required materials and conditions
Exposure duration, after discontinuation and other/long-term infection outcomes
Conditions for verification
Separate original information about Exposure duration, after discontinuation and other/long-term infection outcomes from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Requirement and applicability
Supplementary
Application exceptions
Do not extend 12-week symptom findings into year-round prevention or long-term safety/intake schedules.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: What are persistence, repeated-use or prevention effects beyond 12 weeks?
Referenced methods
M03 §3.2.1–3.2.4; dose, duration and effect-modification details are our own design; M19 §19.1.2–19.2.4; own application
N30 · What was read in the summary, what remains externally unread, and what do source links mean?
Required materials and conditions
Complete existing review summary, abstract/full text/registry and needed materials
Conditions for verification
Separate original information about Complete existing review summary, abstract/full text/registry and needed materials from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Requirement and applicability
Required
Application exceptions
Preserve absent DOI/PMCID fields in the original bibliography; do not declare external acquisition/reading or failed access based on an ID/URL.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: What was read in the summary, what remains externally unread, and what do source links mean?
Referenced methods
M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design
N31 · What are the original bilingual text, dates/corrections, axes, absences and history?
Required materials and conditions
Languages, dates, empty values, parent C50/axes and original verdict narrative
Conditions for verification
Separate original information about Languages, dates, empty values, parent C50/axes and original verdict narrative from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Requirement and applicability
Required
Application exceptions
Do not inherit the original 200-person rule, flaw scoring or cross-check narrative as current clinical review/rescoring, or invent absent fields.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: What are the original bilingual text, dates/corrections, axes, absences and history?
Referenced methods
M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed splitting rules are internally designed; M04 §4.5, §4.6.3; current material-conversion limits follow review scope and internal design; Chamgap’s own independence/attribution conditions. The official methodological sections used in this pilot do not guarantee every detailed item
N32 · What was the original scope of adverse-event collection and related serious safety signals?
Required materials and conditions
Collection/definitions, all events, severity and relatedness
Conditions for verification
Separate original information about Collection/definitions, all events, severity and relatedness from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Requirement and applicability
Supplementary
Application exceptions
Do not turn no reported related serious signal into zero adverse effects of every kind or guaranteed safety.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: What was the original scope of adverse-event collection and related serious safety signals?
Referenced methods
M19 §19.1.2–19.2.4; Detailed distinctions are designed by CHAMGAP
N33 · Are dairy allergy and lactose discomfort actual trial events?
Required materials and conditions
Original cautionary context versus the relevant population/events
Conditions for verification
Separate original information about Original cautionary context versus the relevant population/events from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Requirement and applicability
Supplementary
Application exceptions
Do not create product-checking/avoidance, intake/treatment instructions or allergy/discomfort events absent from the original.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: Are dairy allergy and lactose discomfort actual trial events?
Referenced methods
M19 §19.1.2–19.2.4; Detailed distinctions are internally designed; M19 §19.1.2–19.2.4; Internal application; Chamgap internal interpretation boundaries, informed by M19 principles without running an official causality tool
N34 · Were arm-specific harms, collection populations/denominators and effects verified?
Required materials and conditions
200/198/PPS 193 versus separate harm denominators/comparisons
Conditions for verification
Separate original information about 200/198/PPS 193 versus separate harm denominators/comparisons from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Requirement and applicability
Supplementary
Application exceptions
Do not automatically use PPS 193/97/96 as valid harm denominators or calculate zero events, incidence or CIs.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: Were arm-specific harms, collection populations/denominators and effects verified?
Referenced methods
M19 §19.2.2–19.2.4, M03 §3.2.3; internal application; M19 §19.1.2–19.2.4; internal application
N35 · What were harm timing and post-study/delayed follow-up?
Required materials and conditions
12-week exposure, event/follow-up times and longer-term scope
Conditions for verification
Separate original information about 12-week exposure, event/follow-up times and longer-term scope from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Requirement and applicability
Supplementary
Application exceptions
Do not turn 12-week symptom observation into completed long-term safety verification.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: What were harm timing and post-study/delayed follow-up?
Referenced methods
M19 §19.2 design-specific harm questions; temporal-relationship details are internally designed; M19 §19.1.2–19.2.4; internal application
N36 · How do shared yogurt, baseline/infection exposures and harm relatedness connect?
Required materials and conditions
LG2055/shared ingredients, concurrent drugs/illnesses and alternative causes
Conditions for verification
Separate original information about LG2055/shared ingredients, concurrent drugs/illnesses and alternative causes from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Requirement and applicability
Supplementary
Application exceptions
Do not establish symptoms as outcomes of a specific pathogen or drink-related harm, or add cold-management/treatment instructions.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: How do shared yogurt, baseline/infection exposures and harm relatedness connect?
Referenced methods
Design considerations in M19 §19.2.2–19.2.4; Detailed confounding records are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; Internal application; M08 Table 8.2.a, M03 §3.2.4; Internal application
N37 · Are completion/exclusion and missing diaries distinguished from harm-related discontinuation?
Required materials and conditions
Original 198 completers/5 exclusions, PPS and harm/missingness reasons
Conditions for verification
Separate original information about Original 198 completers/5 exclusions, PPS and harm/missingness reasons from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Requirement and applicability
Supplementary
Application exceptions
Do not convert the original 5 exclusions into people with adverse effects or calculate a new randomized/completer difference.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: Are completion/exclusion and missing diaries distinguished from harm-related discontinuation?
Referenced methods
M19 §19.1.2–19.2.4, M04 §4.6.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application
N38 · How are independent harm data distinguished from observations in the same trial?
Required materials and conditions
Separate safety-report identities, exposures/populations and overlap
Conditions for verification
Separate original information about Separate safety-report identities, exposures/populations and overlap from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Requirement and applicability
Supplementary
Application exceptions
No separate current slot does not establish the absence of all external harm reports.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: How are independent harm data distinguished from observations in the same trial?
Referenced methods
M04 §§4.6.1–4.6.2; harm-material adaptation is Chamgap-designed; M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations
N39 · What is known about vulnerable populations, other illnesses/products and repeated/long-term safety?
Required materials and conditions
Healthy adults versus allergy/illness and long-term scope
Conditions for verification
Separate original information about Healthy adults versus allergy/illness and long-term scope from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Requirement and applicability
Supplementary
Application exceptions
Do not propose implementation instructions for probiotic/product intake, cold management/prevention or treatment substitution.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: What is known about vulnerable populations, other illnesses/products and repeated/long-term safety?
Referenced methods
M19 §19.1.2–19.2.4; Internal application; Design considerations in M19 §19.2.2–19.2.4; Detailed confounding records are internally designed
N40 · Are the causal scopes of symptom-day benefit, infection gaps and the original good safety status distinguished?
Required materials and conditions
Different benefits/events, original safety and harm causality
Conditions for verification
Separate original information about Different benefits/events, original safety and harm causality from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Requirement and applicability
Supplementary
Application exceptions
Do not newly classify unmeasured infection as zero effect, established harm or guaranteed safety.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: Are the causal scopes of symptom-day benefit, infection gaps and the original good safety status distinguished?
Referenced methods
Chamgap internal interpretation boundaries, informed by M19 principles without running an official causality tool; M03 §3.2.4; Internally defined extrapolation boundaries
N41 · How are follow-up materials, historical candidates/versions and incomplete prior content review connected?
Required materials and conditions
Review summary/criteria, original values/units, new materials and user decisions
Conditions for verification
Separate original information about Review summary/criteria, original values/units, new materials and user decisions from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Requirement and applicability
Supplementary
Application exceptions
Do not invent current model/clinical review or completed publication from historical cross-checks or completed production.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: How are follow-up materials, historical candidates/versions and incomplete prior content review connected?
Referenced methods
M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed splitting rules are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M04 §4.5, §4.6.3; current material-conversion limits follow review scope and internal design; M08 Table 8.2.a, M04 §4.6.3; internal application
Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle
Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review
Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle
Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review
Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle
Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review
Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle
Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review
Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle
Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review
Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.
What the statuses mean
Met
The original content has been reviewed as meeting the conditions. This status is not used in this preparation.
Partly verified
Some information in the stored summary was linked during preparation; clinical verification or review is not complete.
Unverified
Required direct values, definitions or materials have not been established within the current storage and reading scope. This does not mean zero effect, no papers or failed access.
Review incomplete
Review of existing content or actual review incomplete.
Not reported
Used only when original materials were actually read and the outcome was judged unreported. Not used for external materials unread in this work.
Inaccessible
Used only when an actual access attempt has a recorded failure. Not used for access that was not attempted in this work.
Insufficient evidence for the conditions
Indicates insufficient direct materials for the relevant scope or conditions; it is not a new grade.
Not applicable
Used when the reason it does not apply to the original question is stated.
Conflicting data
Retains the scope of conflicting statements in original materials; it is not an arbitrary reassessment.

Change history

2026-10-14 · Public page/material version 1.0

The reader view and materials were prepared from the existing 41 items. No new clinical search, verification-status changes or scoring were performed.

The stored-material review date (Not recorded) and original evidence cut-off (2026-08-26) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · How is the selected infection-incidence question distinguished from the symptom-day sheet?

Current findings
The selected existing question is fewer cold infections. Its subclaim record is linked, while fewer days with questionnaire-recorded cold-like symptoms and the original parent context are preserved. No new question, subdivision or trial is created.
Verification status
Partly verified
Materials actually read
Summary read; external materials unread, access not attempted
Why unverified
Some original summary information was linked for production; clinical verification/review is incomplete. No new direct trial or clinical independence has been certified for the selected infection outcome.
Reason for missing information
No new direct trial or clinical independence has been certified for the selected infection outcome.
Required materials and conditions
Infection-incidence question and verdict linkage versus the parent and symptom-day endpoints
Materials to obtain first
Original question, symptom/infection definitions and population/comparator information
Further research
A prespecified research question distinguishing symptom-days from confirmed infection events
Remaining uncertainty
No new direct trial or clinical independence has been certified for the selected infection outcome.
Conditions for verification
Separate original information about Infection-incidence question and verdict linkage versus the parent and symptom-day endpoints from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: How is the selected infection-incidence question distinguished from the symptom-day sheet?
Application exceptions
Do not transfer the sibling C grade or positive symptom-day findings into direct evidence or a grade for infection incidence.
Referenced methods
Question-clarification principles in M03 §3.1, §3.2.1–3.2.4; Detailed separation rules are internally designed; M03 §3.2.4; Internally defined extrapolation boundaries; Distinguishing studies from reports in M04 §4.6.1–4.6.2; Cohort/outcome linkage is an internal application

Related sources R01

N02 · What are the selected grade/note and the absent score, status and axes?

Current findings
The selected ? grade and note that laboratory-confirmed infection incidence was not measured are preserved. The subclaim has no score, status or axes; parent C50 and its axes remain separate historical context.
Verification status
Partly verified
Materials actually read
Summary read; external materials unread, access not attempted
Why unverified
Some original summary information was linked for production; clinical verification/review is incomplete. The original subclaim lacks a score, status and axes.
Reason for missing information
Subclaim score/status/axes are absent in the original.
Required materials and conditions
Subclaim ? grade/note, absent score/status/axes and parent history
Materials to obtain first
Original subclaim and an explicit change event
Further research
Separate preservation of the original grade from updates with additional evidence
Remaining uncertainty
Subclaim score/status/axes are absent in the original.
Conditions for verification
Separate original information about Subclaim ? grade/note, absent score/status/axes and parent history from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: What are the selected grade/note and the absent score, status and axes?
Application exceptions
Do not fill subclaim values or claim a current review pass using the parent score of 50 or symptom-endpoint P/E+ axes.
Referenced methods
M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

Related sources R01

N03 · Who were the actual participants, and how was susceptibility to colds defined?

Current findings
The original records 200 healthy Japanese adults aged 20–64 who were prone to colds. Specific eligibility definitions and medical or immune status are absent from the summary.
Verification status
Partly verified
Materials actually read
Summary read; external materials unread, access not attempted
Why unverified
Some original summary information was linked for production; clinical verification/review is incomplete. Cold susceptibility, baseline history, sex/severity and inclusion/exclusion criteria are unverified.
Reason for missing information
Cold susceptibility, baseline history, sex/severity and inclusion/exclusion criteria are unverified.
Required materials and conditions
Recruitment of healthy Japanese adults aged 20–64 who were prone to colds
Materials to obtain first
Eligibility criteria and baseline characteristics/history
Further research
Research specifying the population and infection/symptom definitions
Remaining uncertainty
Cold susceptibility, baseline history, sex/severity and inclusion/exclusion criteria are unverified.
Conditions for verification
Separate original information about Recruitment of healthy Japanese adults aged 20–64 who were prone to colds from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: Who were the actual participants, and how was susceptibility to colds defined?
Application exceptions
Do not extend healthy-adult findings to infection prevention for all ages, illnesses or immunocompromised people.
Referenced methods
M03 §3.2.1; detailed population conditions are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application

Related sources R01

N04 · What are the identities of the LG2055 study drink and strain?

Current findings
The Korean text records drinkable yogurt containing LG2055; the English text and citation record Lactobacillus paragasseri SBT2055 (LG2055). This study drink and strain are distinguished from generic probiotic products.
Verification status
Partly verified
Materials actually read
Summary read; external materials unread, access not attempted
Why unverified
Some original summary information was linked for production; clinical verification/review is incomplete. Organism count, manufacture/storage, composition and actual product/quality specifications are unverified.
Reason for missing information
Organism count, manufacture/storage, composition and actual product/quality specifications are unverified.
Required materials and conditions
LG2055 drinkable yogurt and the original strain name
Materials to obtain first
Study-drink, strain, quality and exposure specifications
Further research
Research specifying the exact study drink and strain
Remaining uncertainty
Organism count, manufacture/storage, composition and actual product/quality specifications are unverified.
Conditions for verification
Separate original information about LG2055 drinkable yogurt and the original strain name from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: What are the identities of the LG2055 study drink and strain?
Application exceptions
Do not generalize an isolated effect to generic probiotics or other strains/products, or arbitrarily rename the strain.
Referenced methods
M03 §§3.2.2–3.2.3; reverse-direction labels and assessment adaptation are Chamgap-designed; M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed

Related sources R01

N05 · What were the control yogurt and comparison of interest?

Current findings
The original active/control difference was the presence of LG2055; the control was identical yogurt with only LG2055 removed. The comparison was not no yogurt, no treatment or another product.
Verification status
Partly verified
Materials actually read
Summary read; external materials unread, access not attempted
Why unverified
Some original summary information was linked for production; clinical verification/review is incomplete. Equivalence/sensory properties, shared composition and actual exposure/adherence are unverified.
Reason for missing information
Equivalence/sensory properties, shared composition and actual exposure/adherence are unverified.
Required materials and conditions
Identical yogurt with only LG2055 removed and the shared ingredients
Materials to obtain first
Active/control specifications and shared-exposure/blinding information
Further research
Research specifying the contrast on an identical-yogurt background
Remaining uncertainty
Equivalence/sensory properties, shared composition and actual exposure/adherence are unverified.
Conditions for verification
Separate original information about Identical yogurt with only LG2055 removed and the shared ingredients from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: What were the control yogurt and comparison of interest?
Application exceptions
Do not transfer symptom-day results into infection prevention by yogurt as a whole or an isolated LG2055 effect on confirmed infections.
Referenced methods
M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application

Related sources R01

N06 · What were the intake amount, organism count, frequency and actual adherence?

Current findings
The original gives LG2055 yogurt and 12 weeks of observation, but this summary lacks dose/drink volume, organism count, frequency and timing. The 198 intake completers and PPS do not establish actual daily exposure.
Verification status
Partly verified
Materials actually read
Summary read; external materials unread, access not attempted
Why unverified
Some original summary information was linked for production; clinical verification/review is incomplete. Amount/frequency, actual adherence, missed/contaminating exposure and storage conditions are unverified.
Reason for missing information
Amount/frequency, actual adherence, missed/contaminating exposure and storage conditions are unverified.
Required materials and conditions
Target/actual study-drink exposure, adherence and deviations
Materials to obtain first
Study exposure/provision and adherence records
Further research
A plan separating intended provision from actual exposure
Remaining uncertainty
Amount/frequency, actual adherence, missed/contaminating exposure and storage conditions are unverified.
Conditions for verification
Separate original information about Target/actual study-drink exposure, adherence and deviations from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: What were the intake amount, organism count, frequency and actual adherence?
Application exceptions
Do not create intake amounts, dosing instructions or organism-count conversions for probiotics, drinks or products.
Referenced methods
M03 §3.2.2–3.2.3; Reverse-direction labeling and test adaptations are internally designed; M08 §8.2.2, M15 §15.3.1; Internal application; M03 §3.2.1–3.2.4; Dose, persistence and effect-modification details are internally designed

Related sources R01

N07 · What were the 12-week winter observation, follow-up timing and longer-term scope?

Current findings
The original observed questionnaire symptom-days for 12 weeks in winter. Infection-event follow-up, persistence after completion and direct results in other seasons or over longer periods are not separately provided.
Verification status
Partly verified
Materials actually read
Summary read; external materials unread, access not attempted
Why unverified
Some original summary information was linked for production; clinical verification/review is incomplete. Exact visit/observation windows, discontinuation/post-study observations and infection-event follow-up are unverified.
Reason for missing information
Exact visit/observation windows, discontinuation/post-study observations and infection-event follow-up are unverified.
Required materials and conditions
Winter observation, 12 weeks, time points and post-study outcomes
Materials to obtain first
Schedules/questionnaires and exposure/follow-up information
Further research
A plan distinguishing duration and symptom/infection outcomes
Remaining uncertainty
Exact visit/observation windows, discontinuation/post-study observations and infection-event follow-up are unverified.
Conditions for verification
Separate original information about Winter observation, 12 weeks, time points and post-study outcomes from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: What were the 12-week winter observation, follow-up timing and longer-term scope?
Application exceptions
Do not turn 12-week symptom observation into continuous infection prevention or effects across an entire season or the long term.
Referenced methods
M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed

Related sources R01

N08 · Was laboratory-confirmed infection incidence actually measured?

Current findings
The original subclaim note and central explanation state that laboratory-confirmed infection incidence was not measured. Questionnaire symptom-days are not direct results for the selected infection events.
Verification status
Unverified
Materials actually read
Summary read; external materials unread, access not attempted
Why unverified
The needed direct information was not verified within the current summary and unread-external-material scope. Pathogens/testing, confirmed events/denominators and direct comparative effects/CIs are unverified.
Reason for missing information
Pathogens/testing, confirmed events/denominators and direct comparative effects/CIs are unverified.
Required materials and conditions
Pathogen-confirmed infection events and testing/diagnostic definitions
Materials to obtain first
Research directly measuring confirmed infections, with test/event definitions
Further research
Research defining symptom questionnaires and confirmed infection events separately
Remaining uncertainty
Pathogens/testing, confirmed events/denominators and direct comparative effects/CIs are unverified.
Conditions for verification
Separate original information about Pathogen-confirmed infection events and testing/diagnostic definitions from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: Was laboratory-confirmed infection incidence actually measured?
Application exceptions
Preserve the original statement of nonmeasurement without newly judging infection incidence or effects as zero, or prevention as successful.
Referenced methods
M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 Table 8.2.a and M03 §3.2.4; Chamgap application; M03 §3.2.4; Chamgap interpretation boundary

Related sources R01

N09 · What was the scope of clinician confirmation, pathogen types and testing times?

Current findings
The original distinguishes questionnaire-recorded cold-like symptoms from laboratory-confirmed cold outcomes. Details of clinician-confirmed infections, pathogen types and test timing/diagnosis are not separately given.
Verification status
Unverified
Materials actually read
Summary read; external materials unread, access not attempted
Why unverified
The needed direct information was not verified within the current summary and unread-external-material scope. Clinician adjudication, testing/pathogens, positivity criteria and event timing are unverified.
Reason for missing information
Clinician adjudication, testing/pathogens, positivity criteria and event timing are unverified.
Required materials and conditions
Clinician/test confirmation, pathogens/timing and the distinction from similar symptoms
Materials to obtain first
Clinician/test-confirmed infections and original adjudication/testing information
Further research
Research defining confirmation methods, pathogens and observation times
Remaining uncertainty
Clinician adjudication, testing/pathogens, positivity criteria and event timing are unverified.
Conditions for verification
Separate original information about Clinician/test confirmation, pathogens/timing and the distinction from similar symptoms from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: What was the scope of clinician confirmation, pathogen types and testing times?
Application exceptions
Do not invent clinician adjudication or testing absent from the summary, or attribute symptoms to a particular infection.
Referenced methods
M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 Table 8.2.a and M03 §3.2.4; Chamgap application; M03 §3.2.4; Chamgap interpretation boundary

Related sources R01

N10 · Are there infected-person counts, first/recurrent events and incidence denominators?

Current findings
The current summary supplies symptom-day aggregates. It lacks people infected at least once, first/recurrent infection events, confirmed-incidence numerators/denominators and follow-up.
Verification status
Unverified
Materials actually read
Summary read; external materials unread, access not attempted
Why unverified
The needed direct information was not verified within the current summary and unread-external-material scope. Infected people/events, incidence, time/denominators and effects of interest/CIs are unverified.
Reason for missing information
Infected people/events, incidence, time/denominators and effects of interest/CIs are unverified.
Required materials and conditions
People/events, time at risk, reinfections/repeats and denominators
Materials to obtain first
Infection-event/person flow, time at risk and direct results
Further research
Research distinguishing first/recurrent events and person/time denominators
Remaining uncertainty
Infected people/events, incidence, time/denominators and effects of interest/CIs are unverified.
Conditions for verification
Separate original information about People/events, time at risk, reinfections/repeats and denominators from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: Are there infected-person counts, first/recurrent events and incidence denominators?
Application exceptions
Do not convert symptom-day proportions into proportions of infected people, infection-event counts or incidence.
Referenced methods
M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are internally designed; M08 §8.2.2, M15 §15.3.1; Internal application; M03 §3.2.4; Internally defined extrapolation boundaries

Related sources R01

N11 · What units underlie the original runny-nose numerators, denominators and absolute difference?

Current findings
Original runny-nose days were 2,384/8,148 days (29.3%) versus 2,769/8,066 days (34.3%), with an absolute difference of −5.0 percentage points and P<0.001. These are preserved as aggregate symptom/observation days, not infection-event or person values.
Verification status
Partly verified
Materials actually read
Summary read; external materials unread, access not attempted
Why unverified
Some original summary information was linked for production; clinical verification/review is incomplete. Exact observation-day definitions, repeated/missing-data handling, denominator aggregation and CIs are unverified.
Reason for missing information
Exact observation-day definitions, repeated/missing-data handling, denominator aggregation and CIs are unverified.
Required materials and conditions
2,384/8,148 days versus 2,769/8,066 days, proportions and the original difference
Materials to obtain first
Questionnaire/aggregation definitions, original daily data and denominator/analysis tables
Further research
A plan distinguishing estimands for people, observation days and symptom-days
Remaining uncertainty
Exact observation-day definitions, repeated/missing-data handling, denominator aggregation and CIs are unverified.
Conditions for verification
Separate original information about 2,384/8,148 days versus 2,769/8,066 days, proportions and the original difference from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: What units underlie the original runny-nose numerators, denominators and absolute difference?
Application exceptions
Do not recalculate the original −5.0 percentage points or convert it into infection risk differences, RR/NNT or individual prevention probabilities.
Referenced methods
M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application

Related sources R01

N12 · What do the other symptom proportions and cough P value mean?

Current findings
Original nasal-congestion 17.7/27.7%, sneezing 17.7/20.2%, sore-throat 6.3/12.2%, hoarseness 3.5/8.2% and cough P<0.001 are preserved. Each symptom is neither an infection-confirmation outcome nor an independent trial.
Verification status
Partly verified
Materials actually read
Summary read; external materials unread, access not attempted
Why unverified
Some original summary information was linked for production; clinical verification/review is incomplete. Symptom-specific numerators/denominators, CIs, definitions/hierarchy and multiplicity are unverified.
Reason for missing information
Symptom-specific numerators/denominators, CIs, definitions/hierarchy and multiplicity are unverified.
Required materials and conditions
Original symptom-days for nasal congestion, sneezing, sore throat, hoarseness and cough
Materials to obtain first
Each symptom's definition, denominator, analysis and plan
Further research
Research specifying symptom-specific outcomes and the planned hierarchy
Remaining uncertainty
Symptom-specific numerators/denominators, CIs, definitions/hierarchy and multiplicity are unverified.
Conditions for verification
Separate original information about Original symptom-days for nasal congestion, sneezing, sore throat, hoarseness and cough from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: What do the other symptom proportions and cough P value mean?
Application exceptions
Do not combine symptoms or time points into new confirmed-infection counts or a composite success score.
Referenced methods
M04 §4.6.3, M15 §15.3.1–15.3.3; Status separation is internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M04 §4.6.3; Internal application; M03 §3.2.4; Internally defined extrapolation boundaries

Related sources R01

N13 · What are the analysis units for people, observation days, symptoms and repeated records?

Current findings
The 200 participants/PPS 193 and aggregate 8,148/8,066 observation days are different units. Multiple days or symptoms from the same person are not added as new independent participants or trials.
Verification status
Unverified
Materials actually read
Summary read; external materials unread, access not attempted
Why unverified
The needed direct information was not verified within the current summary and unread-external-material scope. Within-person correlation, concurrent symptoms, aggregation/models and each person's observation duration are unverified.
Reason for missing information
Within-person correlation, concurrent symptoms, aggregation/models and each person's observation duration are unverified.
Required materials and conditions
Repeated diaries from the same people, symptoms/groups/times and correlation
Materials to obtain first
Individual diaries and denominator/repeated-measures analysis plans
Further research
Research distinguishing people, repeated records and events
Remaining uncertainty
Within-person correlation, concurrent symptoms, aggregation/models and each person's observation duration are unverified.
Conditions for verification
Separate original information about Repeated diaries from the same people, symptoms/groups/times and correlation from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: What are the analysis units for people, observation days, symptoms and repeated records?
Application exceptions
Do not reanalyze all observation days as independent binary observations or inflate the sample size.
Referenced methods
Distinguishing studies from reports in M04 §4.6.1–4.6.2; Cohort/outcome linkage is an internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are internally designed; M08 Table 8.2.a, M03 §3.2.4; Internal application; M08 §8.2.2, M15 §15.3.1; Internal application

Related sources R01

N14 · Are questionnaire missingness, recording adherence and unmeasured infections distinguished?

Current findings
The original supplies questionnaire symptom-days, PPS analysis and aggregate observation days, but lacks missing diaries/nonresponse, symptom handling and individual observation days. Unmeasured confirmed infection is a different gap from missing diaries.
Verification status
Unverified
Materials actually read
Summary read; external materials unread, access not attempted
Why unverified
The needed direct information was not verified within the current summary and unread-external-material scope. Missingness/nonresponse, aggregation/imputation, individual day counts and infection data are unverified.
Reason for missing information
Missingness/nonresponse, aggregation/imputation, individual day counts and infection data are unverified.
Required materials and conditions
Missing diaries/symptoms, unmeasured infections and imputation/denominators
Materials to obtain first
Questionnaire adherence/missingness, denominator rules and SAP
Further research
A plan distinguishing missing records from unmeasured infection events
Remaining uncertainty
Missingness/nonresponse, aggregation/imputation, individual day counts and infection data are unverified.
Conditions for verification
Separate original information about Missing diaries/symptoms, unmeasured infections and imputation/denominators from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: Are questionnaire missingness, recording adherence and unmeasured infections distinguished?
Application exceptions
Do not fill missing days as symptom-free/infection-free or treat unmeasured infection as a zero effect.
Referenced methods
M08 Table 8.2.a, M03 §3.2.4; Internal application; M08 §8.2.2, M15 §15.3.1; Internal application; M08 Table 8.2.a, M04 §4.6.3; Internal application

Related sources R01

N15 · What were the prespecified primary, symptom-specific/secondary and composite outcomes and multiplicity rules?

Current findings
The original describes questionnaire symptom-days as primary and states that multiple symptoms were not tested as a single prespecified hierarchical composite score. External plans for individual, secondary/exploratory outcomes and multiplicity were not read.
Verification status
Partly verified
Materials actually read
Summary read; external materials unread, access not attempted
Why unverified
Some original summary information was linked for production; clinical verification/review is incomplete. Prespecified lists/hierarchy, multiplicity, success criteria and secondary analyses are unverified.
Reason for missing information
Prespecified lists/hierarchy, multiplicity, success criteria and secondary analyses are unverified.
Required materials and conditions
Original primary symptom-days, hierarchical composite and secondary hierarchy
Materials to obtain first
Registry/protocol/SAP and the complete outcome list
Further research
Research prespecifying symptom/infection and primary/secondary estimands
Remaining uncertainty
Prespecified lists/hierarchy, multiplicity, success criteria and secondary analyses are unverified.
Conditions for verification
Separate original information about Original primary symptom-days, hierarchical composite and secondary hierarchy from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: What were the prespecified primary, symptom-specific/secondary and composite outcomes and multiplicity rules?
Application exceptions
Do not establish overall infection-prevention efficacy or a new composite outcome from one selected positive symptom.
Referenced methods
M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap design; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap design

Related sources R01

N16 · What was the original discrepancy between the registry ID, claimed preregistration and public date?

Current findings
The original says the paper claimed registration before study start, but the UMIN public date 2022-09-08 followed the planned start 2021-10-30, making registration retrospective by the public record. This historical discrepancy is preserved; the external registry was not newly verified.
Verification status
Partly verified
Materials actually read
Summary read; external materials unread, access not attempted
Why unverified
Some original summary information was linked for production; clinical verification/review is incomplete. Actual registry versions, amendment/public/start details and original prespecified plans remain unread.
Reason for missing information
Actual registry versions, amendment/public/start details and original prespecified plans remain unread.
Required materials and conditions
UMIN000045901, original planned-start/public dates and unread external records
Materials to obtain first
Registry versions/timing, protocol/SAP and comparison with the original paper
Further research
Records separating plans from publication/amendment events
Remaining uncertainty
Actual registry versions, amendment/public/start details and original prespecified plans remain unread.
Conditions for verification
Separate original information about UMIN000045901, original planned-start/public dates and unread external records from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: What was the original discrepancy between the registry ID, claimed preregistration and public date?
Application exceptions
Do not replace UMIN with NCT, calculate the date gap or upgrade it to a current registry-review pass.
Referenced methods
M08 Table 8.2.a, M04 §4.6.3; Internal application; M04 §4.5, §4.6.3; Current conversion limits follow the review scope and internal design; Collection/selection principles in M04 §4.5–4.6; Separating access from reading and the hyperlink contract are internally designed

Related sources R01

N17 · What were the actual randomization, identical-yogurt and double-blinding procedures?

Current findings
The original design is a double-blind randomized identical-yogurt placebo-controlled parallel trial. The summary lacks sequence/concealment, who was blinded, equivalence and awareness-of-condition details.
Verification status
Partly verified
Materials actually read
Summary read; external materials unread, access not attempted
Why unverified
Some original summary information was linked for production; clinical verification/review is incomplete. Allocation/concealment, baseline balance and blinding/sensory/awareness procedures are unverified.
Reason for missing information
Allocation/concealment, baseline balance and blinding/sensory/awareness procedures are unverified.
Required materials and conditions
Allocation/concealment, baseline balance, blinding and awareness of conditions
Materials to obtain first
Allocation/blinding and baseline/equivalence tables
Further research
An allocation/blinding plan for identical yogurt
Remaining uncertainty
Allocation/concealment, baseline balance and blinding/sensory/awareness procedures are unverified.
Conditions for verification
Separate original information about Allocation/concealment, baseline balance, blinding and awareness of conditions from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: What were the actual randomization, identical-yogurt and double-blinding procedures?
Application exceptions
Do not certify successful blinding, absence of bias or independence from the original design label or B1 axis.
Referenced methods
M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application

Related sources R01

N18 · What were the original randomized, intake-completer, exclusion and PPS counts?

Current findings
The original 200 randomized, 100 assigned per arm, 198 intake completers, 5 exclusions and PPS primary-efficacy population of 193 (97/96) are preserved. Detailed arm-specific flow and endpoint observations are absent.
Verification status
Partly verified
Materials actually read
Summary read; external materials unread, access not attempted
Why unverified
Some original summary information was linked for production; clinical verification/review is incomplete. Arm-specific completion/exclusion reasons, detailed PPS 97/96 mapping and endpoint denominators are unverified.
Reason for missing information
Arm-specific completion/exclusion reasons, detailed PPS 97/96 mapping and endpoint denominators are unverified.
Required materials and conditions
200, 100 per arm, 198 completers, original 5 exclusions and 193 (97/96)
Materials to obtain first
Participant flow, arm/endpoint denominators and PPS definition
Further research
A plan distinguishing randomized, completer and analysis populations
Remaining uncertainty
Arm-specific completion/exclusion reasons, detailed PPS 97/96 mapping and endpoint denominators are unverified.
Conditions for verification
Separate original information about 200, 100 per arm, 198 completers, original 5 exclusions and 193 (97/96) from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: What were the original randomized, intake-completer, exclusion and PPS counts?
Application exceptions
Do not calculate or add new dropout/exclusion counts or proportions from 200/198/193.
Referenced methods
M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application

Related sources R01

N19 · What were the PPS, completer, ITT and other analysis populations and missing-data handling?

Current findings
Original primary efficacy concerns 193 per-protocol completers, not all 200 randomized participants. All-randomized/ITT analysis, imputation, sensitivity and adherence-effect details are not supplied.
Verification status
Partly verified
Materials actually read
Summary read; external materials unread, access not attempted
Why unverified
Some original summary information was linked for production; clinical verification/review is incomplete. PPS selection, analysis models, ITT/imputation, sensitivity and missingness/attrition reasons are unverified.
Reason for missing information
PPS selection, analysis models, ITT/imputation, sensitivity and missingness/attrition reasons are unverified.
Required materials and conditions
Original primary-efficacy PPS versus the estimand for all randomized participants
Materials to obtain first
SAP, analysis populations/flow and missing-data results
Further research
Research prespecifying assignment/adherence effects and missingness
Remaining uncertainty
PPS selection, analysis models, ITT/imputation, sensitivity and missingness/attrition reasons are unverified.
Conditions for verification
Separate original information about Original primary-efficacy PPS versus the estimand for all randomized participants from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: What were the PPS, completer, ITT and other analysis populations and missing-data handling?
Application exceptions
Do not replicate symptom-day PPS findings as direct effects for all randomized people or confirmed-infection populations.
Referenced methods
M08 §8.2.2, M15 §15.3.1; Internal application; M08 Table 8.2.a, M04 §4.6.3; Internal application

Related sources R01

N20 · Were baseline infection risk and shared lifestyle/treatment exposures verified?

Current findings
The original supplies healthy adults prone to colds, identical yogurt and winter context. Detailed arm-specific baseline infection risk, concurrent drugs/lifestyle and exposure/environment are absent.
Verification status
Unverified
Materials actually read
Summary read; external materials unread, access not attempted
Why unverified
The needed direct information was not verified within the current summary and unread-external-material scope. Baseline/changed medication, lifestyle/infection exposure, shared support and arm differences are unverified.
Reason for missing information
Baseline/changed medication, lifestyle/infection exposure, shared support and arm differences are unverified.
Required materials and conditions
Cold susceptibility, concurrent exposures/drugs, arm-specific risk and shared conditions
Materials to obtain first
Baseline/concurrent exposures, protocol and visit records
Further research
Research specifying shared conditions and infection risk
Remaining uncertainty
Baseline/changed medication, lifestyle/infection exposure, shared support and arm differences are unverified.
Conditions for verification
Separate original information about Cold susceptibility, concurrent exposures/drugs, arm-specific risk and shared conditions from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: Were baseline infection risk and shared lifestyle/treatment exposures verified?
Application exceptions
Do not add infection-prevention/treatment components absent from the original as actual trial exposures or instructions.
Referenced methods
M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M03 §3.2.1; detailed population conditions are internally designed; M19 §19.2.2–19.2.4 design considerations; detailed confounding records are internally designed

Related sources R01

N21 · How were subjective questionnaires collected and adjudicated?

Current findings
The endpoint is days with questionnaire-recorded cold-like symptoms. Symptom criteria, recording frequency/severity, assessment/adjudication and links to testing are not detailed.
Verification status
Partly verified
Materials actually read
Summary read; external materials unread, access not attempted
Why unverified
Some original summary information was linked for production; clinical verification/review is incomplete. Diary/assessment methods, symptom thresholds, confirmation/classification and severity procedures are unverified.
Reason for missing information
Diary/assessment methods, symptom thresholds, confirmation/classification and severity procedures are unverified.
Required materials and conditions
Diaries, symptom definitions/severity and assessors versus testing
Materials to obtain first
Questionnaire/diary forms, symptom definitions and collection/adjudication methods
Further research
A measurement plan separating subjective symptoms from confirmed infection
Remaining uncertainty
Diary/assessment methods, symptom thresholds, confirmation/classification and severity procedures are unverified.
Conditions for verification
Separate original information about Diaries, symptom definitions/severity and assessors versus testing from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: How were subjective questionnaires collected and adjudicated?
Application exceptions
Do not automatically classify symptomatic colds as clinician/test-confirmed diagnoses.
Referenced methods
M08 Table 8.2.a, M03 §3.2.4; own application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific result adaptation is our own design

Related sources R01

N22 · What were the original unreported CIs, precision and missing direct infection estimates?

Current findings
The original states that between-group 95% CIs for symptom-days were not provided. Effects/CIs for the selected confirmed-infection incidence are also unavailable. This run did not newly review nonreporting in the external paper.
Verification status
Partly verified
Materials actually read
Summary read; external materials unread, access not attempted
Why unverified
Some original summary information was linked for production; clinical verification/review is incomplete. Symptom-day models/intervals, repeated correlation, direct infection effects/intervals and clinical importance are unverified.
Reason for missing information
Symptom-day models/intervals, repeated correlation, direct infection effects/intervals and clinical importance are unverified.
Required materials and conditions
Original symptom-day −5.0 percentage points/P, absent 95% CI and the infection-estimate gap
Materials to obtain first
Analysis results/SAP and direct infection data
Further research
Research specifying units, estimands and precision
Remaining uncertainty
Symptom-day models/intervals, repeated correlation, direct infection effects/intervals and clinical importance are unverified.
Conditions for verification
Separate original information about Original symptom-day −5.0 percentage points/P, absent 95% CI and the infection-estimate gap from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: What were the original unreported CIs, precision and missing direct infection estimates?
Application exceptions
Do not calculate new CI/RR/NNT from aggregate days or transfer them into infection-effect estimates.
Referenced methods
M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are internally designed; M15 §15.3.1–15.3.3; Internal application; M04 §4.5, §4.6.3; Current conversion limits follow the review scope and internal design

Related sources R01

N23 · Are within/between-group symptom-days, periods and event estimands distinguished?

Current findings
The original gives 12-week aggregates of days with symptoms and between-group proportion differences. Individual symptom-day changes, adjustments/models and confirmed-infection event contrasts are not separately detailed.
Verification status
Partly verified
Materials actually read
Summary read; external materials unread, access not attempted
Why unverified
Some original summary information was linked for production; clinical verification/review is incomplete. Individual/period-specific data, baseline/adjustment, estimands and infection-event definitions are unverified.
Reason for missing information
Individual/period-specific data, baseline/adjustment, estimands and infection-event definitions are unverified.
Required materials and conditions
Original day-proportion contrast versus individuals/infection, adjustment and models
Materials to obtain first
Individual/aggregate results, estimands/models and direct infection data
Further research
Research separating symptom-days, people/events and within/between-group contrasts
Remaining uncertainty
Individual/period-specific data, baseline/adjustment, estimands and infection-event definitions are unverified.
Conditions for verification
Separate original information about Original day-proportion contrast versus individuals/infection, adjustment and models from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: Are within/between-group symptom-days, periods and event estimands distinguished?
Application exceptions
Do not interpret aggregate proportions as reduced individual infection risk or guaranteed prevention.
Referenced methods
M08 §8.2.2, M15 §15.3.1; Internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are internally designed; M03 §3.2.4; Internally defined extrapolation boundaries

Related sources R01

N24 · What were the original sponsor, employee/contractor and product-development details?

Current findings
The original describes EK, TA, MK and TK as MEGMILK SNOW BRAND employees, NS as a KSO Corporation employee and LG2055 drinkable yogurt as company-developed. Its statement that separate public cofunding, medical writing and publication-cost support were not identified is also preserved.
Verification status
Partly verified
Materials actually read
Summary read; external materials unread, access not attempted
Why unverified
Some original summary information was linked for production; clinical verification/review is incomplete. Current details of original disclosures/support and design/analysis/data-access roles remain unread.
Reason for missing information
Current details of original disclosures/support and design/analysis/data-access roles remain unread.
Required materials and conditions
Four MEGMILK employees, a KSO employee and product/support scope
Materials to obtain first
Original support/product-provision, author/contractor-role and disclosure records
Further research
Explicit support and research-decision/analysis roles
Remaining uncertainty
Current details of original disclosures/support and design/analysis/data-access roles remain unread.
Conditions for verification
Separate original information about Four MEGMILK employees, a KSO employee and product/support scope from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: What were the original sponsor, employee/contractor and product-development details?
Application exceptions
Do not add the contractor employee to the four company employees or regrade original values solely because of sponsorship.
Referenced methods
Chamgap’s own independence/attribution conditions. The official methodological sections used in this pilot do not guarantee every detailed item; M08 §8.1–8.2.3; internal application

Related sources R01

N25 · Are reports/trials, symptoms/person-days and sibling sheets linked to the same family?

Current findings
The single current evidence/citation entry for Kobatake 2022 is linked as one report slot. People, arms, days, symptoms, times and sibling sheets share the original context; they are not new independent trials or participants to be added.
Verification status
Partly verified
Materials actually read
Summary read; external materials unread, access not attempted
Why unverified
Some original summary information was linked for production; clinical verification/review is incomplete. Related report/trial relationships and unique trial/participant totals are unverified.
Reason for missing information
Related report/trial relationships and unique trial/participant totals are unverified.
Required materials and conditions
Kobatake 2022 citation and relationships within the same population/observations
Materials to obtain first
Trial/related-report identities and observation-unit information
Further research
Records distinguishing reports from study families
Remaining uncertainty
Related report/trial relationships and unique trial/participant totals are unverified.
Conditions for verification
Separate original information about Kobatake 2022 citation and relationships within the same population/observations from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: Are reports/trials, symptoms/person-days and sibling sheets linked to the same family?
Application exceptions
One report slot does not certify one direct confirmed-infection trial or a final clinically independent count.
Referenced methods
Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application

Related sources R01

N26 · Is there direct replication or independent confirmation for confirmed infection?

Current findings
Parent R1/I0 and the single manufacturer-program trial are historical symptom-day context. Direct original data for independent replication of the selected confirmed-infection outcome were not searched for or acquired in this run.
Verification status
Unverified
Materials actually read
Summary read; external materials unread, access not attempted
Why unverified
The needed direct information was not verified within the current summary and unread-external-material scope. Direct confirmed-infection reports, populations/strains/testing and overlap/independence are unverified.
Reason for missing information
Direct confirmed-infection reports, populations/strains/testing and overlap/independence are unverified.
Required materials and conditions
Direct trials of the selected infection incidence, confirmation methods and identities
Materials to obtain first
Direct infection-confirmation/replication reports and trial identities
Further research
Separate research defining confirmed-infection events
Remaining uncertainty
Direct confirmed-infection reports, populations/strains/testing and overlap/independence are unverified.
Conditions for verification
Separate original information about Direct trials of the selected infection incidence, confirmation methods and identities from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: Is there direct replication or independent confirmation for confirmed infection?
Application exceptions
Do not count sibling symptom reports as independent infection trials or extend the original single trial into a current worldwide absence-of-research finding.
Referenced methods
Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application

Related sources R01

N27 · What is the applicability to other products/strains, populations and settings?

Current findings
The original concerns symptom-days in healthy Japanese adults aged 20–64 during winter using LG2055 and identical yogurt. Confirmed-infection effects for other strains/products, populations or seasons are not given.
Verification status
Partly verified
Materials actually read
Summary read; external materials unread, access not attempted
Why unverified
Some original summary information was linked for production; clinical verification/review is incomplete. Direct effects, CIs and interactions by population, strain, product and setting are unverified.
Reason for missing information
Direct effects, CIs and interactions by population, strain, product and setting are unverified.
Required materials and conditions
Original LG2055 identical-yogurt/winter-adult context versus other scopes
Materials to obtain first
Exact formulation/population and confirmed-infection data
Further research
Research prespecifying direct applicability
Remaining uncertainty
Direct effects, CIs and interactions by population, strain, product and setting are unverified.
Conditions for verification
Separate original information about Original LG2055 identical-yogurt/winter-adult context versus other scopes from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: What is the applicability to other products/strains, populations and settings?
Application exceptions
Do not extend findings into general immune improvement, prevention of all infections, product recommendations or intake instructions.
Referenced methods
M03 §3.2.1; Detailed population conditions are internally designed; M03 §3.2.2–3.2.3; Reverse-direction labeling and test adaptations are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; Internal application; M03 §3.2.1–3.2.4; Dose, persistence and effect-modification details are internally designed

Related sources R01

N28 · Are fewer symptom-days distinguished from infection prevention and important clinical outcomes?

Current findings
The original summary and central explanation state that fewer symptom-days do not establish prevention of cold infections themselves. Direct values for immunity, clinical visits/hospitalization and serious infection are also absent.
Verification status
Partly verified
Materials actually read
Summary read; external materials unread, access not attempted
Why unverified
Some original summary information was linked for production; clinical verification/review is incomplete. Direct infection and patient-important/clinical events, effects, denominators and CIs are unverified.
Reason for missing information
Direct infection and patient-important/clinical events, effects, denominators and CIs are unverified.
Required materials and conditions
Questionnaire symptoms, confirmed infection and immune/serious clinical outcomes
Materials to obtain first
Direct-event and patient-important-outcome information
Further research
A plan separating symptom questions from confirmed-infection/clinical questions
Remaining uncertainty
Direct infection and patient-important/clinical events, effects, denominators and CIs are unverified.
Conditions for verification
Separate original information about Questionnaire symptoms, confirmed infection and immune/serious clinical outcomes from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: Are fewer symptom-days distinguished from infection prevention and important clinical outcomes?
Application exceptions
Do not turn positive symptom-day findings into laboratory-confirmed prevention, improved immunity or treatment substitution.
Referenced methods
M03 §3.2.4; internally defined extension boundary; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed

Related sources R01

N29 · What are persistence, repeated-use or prevention effects beyond 12 weeks?

Current findings
The original observation concerns 12-week symptom-days. Persistence after discontinuation, repeated/longer use and long-term confirmed-infection outcomes are absent.
Verification status
Partly verified
Materials actually read
Summary read; external materials unread, access not attempted
Why unverified
Some original summary information was linked for production; clinical verification/review is incomplete. Direct post-study/long-term benefits/harms, denominators and CIs are unverified.
Reason for missing information
Direct post-study/long-term benefits/harms, denominators and CIs are unverified.
Required materials and conditions
Exposure duration, after discontinuation and other/long-term infection outcomes
Materials to obtain first
Exposure/post-study and direct long-term results
Further research
Research distinguishing persistence/repetition questions from infection events
Remaining uncertainty
Direct post-study/long-term benefits/harms, denominators and CIs are unverified.
Conditions for verification
Separate original information about Exposure duration, after discontinuation and other/long-term infection outcomes from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: What are persistence, repeated-use or prevention effects beyond 12 weeks?
Application exceptions
Do not extend 12-week symptom findings into year-round prevention or long-term safety/intake schedules.
Referenced methods
M03 §3.2.1–3.2.4; dose, duration and effect-modification details are our own design; M19 §19.1.2–19.2.4; own application

Related sources R01

N30 · What was read in the summary, what remains externally unread, and what do source links mean?

Current findings
The complete preserved 2977 summary was read and saved for production. Original PubMed and UMIN references are source connections; external content/link access, clicking and testing were not performed in that production.
Verification status
Partly verified
Materials actually read
Summary read; external materials unread, access not attempted
Why unverified
Some original summary information was linked for production; clinical verification/review is incomplete. Current external-method/result and registry/planning details remain unverified.
Reason for missing information
Current external-method/result and registry/planning details remain unverified.
Required materials and conditions
Complete existing review summary, abstract/full text/registry and needed materials
Materials to obtain first
Acquired original materials and actual reading/additional events
Further research
Records separating summary preservation from newly acquired materials
Remaining uncertainty
Current external-method/result and registry/planning details remain unverified.
Conditions for verification
Separate original information about Complete existing review summary, abstract/full text/registry and needed materials from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: What was read in the summary, what remains externally unread, and what do source links mean?
Application exceptions
Preserve absent DOI/PMCID fields in the original bibliography; do not declare external acquisition/reading or failed access based on an ID/URL.
Referenced methods
M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

Related sources R01

N31 · What are the original bilingual text, dates/corrections, axes, absences and history?

Current findings
Bilingual text, the original date 2026-08-26 and empty correction/deliberation records are preserved. Parent C50, B/P/R1/I0/E+/B1, unrecorded precision, three false flags and empty grade-override reasons are historical; separate classification and primary-failure/secondary-positive fields are absent.
Verification status
Partly verified
Materials actually read
Summary read; external materials unread, access not attempted
Why unverified
Some original summary information was linked for production; clinical verification/review is incomplete. External detailed translation, registry/original-text and correction comparisons were not performed in this run.
Reason for missing information
External detailed translation, registry/original-text and correction comparisons were not performed in this run.
Required materials and conditions
Languages, dates, empty values, parent C50/axes and original verdict narrative
Materials to obtain first
Original text, language-specific revisions and dated correction events
Further research
Separate original values/absences from new updates
Remaining uncertainty
External detailed translation, registry/original-text and correction comparisons were not performed in this run.
Conditions for verification
Separate original information about Languages, dates, empty values, parent C50/axes and original verdict narrative from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: What are the original bilingual text, dates/corrections, axes, absences and history?
Application exceptions
Do not inherit the original 200-person rule, flaw scoring or cross-check narrative as current clinical review/rescoring, or invent absent fields.
Referenced methods
M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed splitting rules are internally designed; M04 §4.5, §4.6.3; current material-conversion limits follow review scope and internal design; Chamgap’s own independence/attribution conditions. The official methodological sections used in this pilot do not guarantee every detailed item

Related sources R01

N32 · What was the original scope of adverse-event collection and related serious safety signals?

Current findings
The original records no reported serious safety signal related to the test food in the 12-week trial. Collection methods/definitions, all events and relatedness-adjudication tables are absent.
Verification status
Partly verified
Materials actually read
Summary read; external materials unread, access not attempted
Why unverified
Some original summary information was linked for production; clinical verification/review is incomplete. Harm collection, all/serious events, relatedness and discontinuation tables are unverified.
Reason for missing information
Harm collection, all/serious events, relatedness and discontinuation tables are unverified.
Required materials and conditions
Collection/definitions, all events, severity and relatedness
Materials to obtain first
Harm plans, all-event/discontinuation and relatedness tables
Further research
Research specifying harm collection separately from efficacy
Remaining uncertainty
Harm collection, all/serious events, relatedness and discontinuation tables are unverified.
Conditions for verification
Separate original information about Collection/definitions, all events, severity and relatedness from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: What was the original scope of adverse-event collection and related serious safety signals?
Application exceptions
Do not turn no reported related serious signal into zero adverse effects of every kind or guaranteed safety.
Referenced methods
M19 §19.1.2–19.2.4; Detailed distinctions are designed by CHAMGAP

Related sources R01

N33 · Are dairy allergy and lactose discomfort actual trial events?

Current findings
The original mentions dairy allergy and lactose-related discomfort in the product-ingredient context. This is not a count or causal result showing those events occurred in this trial.
Verification status
Partly verified
Materials actually read
Summary read; external materials unread, access not attempted
Why unverified
Some original summary information was linked for production; clinical verification/review is incomplete. Population selection, actual events/denominators, severity and relatedness are unverified.
Reason for missing information
Population selection, actual events/denominators, severity and relatedness are unverified.
Required materials and conditions
Original cautionary context versus the relevant population/events
Materials to obtain first
Relevant populations/events and exposure/relatedness information
Further research
Research specifying safety questions for vulnerable populations
Remaining uncertainty
Population selection, actual events/denominators, severity and relatedness are unverified.
Conditions for verification
Separate original information about Original cautionary context versus the relevant population/events from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: Are dairy allergy and lactose discomfort actual trial events?
Application exceptions
Do not create product-checking/avoidance, intake/treatment instructions or allergy/discomfort events absent from the original.
Referenced methods
M19 §19.1.2–19.2.4; Detailed distinctions are internally designed; M19 §19.1.2–19.2.4; Internal application; Chamgap internal interpretation boundaries, informed by M19 principles without running an official causality tool

Related sources R01

N34 · Were arm-specific harms, collection populations/denominators and effects verified?

Current findings
It is unverified whether randomized/completer/PPS populations match the harm-collection population. The summary lacks arm-specific harm events/denominators, comparisons and CIs.
Verification status
Unverified
Materials actually read
Summary read; external materials unread, access not attempted
Why unverified
The needed direct information was not verified within the current summary and unread-external-material scope. Arm/period-specific collection, events/exposure denominators and comparative effects/CIs are unverified.
Reason for missing information
Arm/period-specific collection, events/exposure denominators and comparative effects/CIs are unverified.
Required materials and conditions
200/198/PPS 193 versus separate harm denominators/comparisons
Materials to obtain first
Harm flow and arm-specific event/denominator tables
Further research
Research distinguishing efficacy populations from harm-collection populations
Remaining uncertainty
Arm/period-specific collection, events/exposure denominators and comparative effects/CIs are unverified.
Conditions for verification
Separate original information about 200/198/PPS 193 versus separate harm denominators/comparisons from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: Were arm-specific harms, collection populations/denominators and effects verified?
Application exceptions
Do not automatically use PPS 193/97/96 as valid harm denominators or calculate zero events, incidence or CIs.
Referenced methods
M19 §19.2.2–19.2.4, M03 §3.2.3; internal application; M19 §19.1.2–19.2.4; internal application

Related sources R01

N35 · What were harm timing and post-study/delayed follow-up?

Current findings
The original has a 12-week safety narrative but no separate event timing, period-specific observation or post-study/delayed-harm data.
Verification status
Unverified
Materials actually read
Summary read; external materials unread, access not attempted
Why unverified
The needed direct information was not verified within the current summary and unread-external-material scope. Event timing, post-discontinuation/long-term observation and exposure changes are unverified.
Reason for missing information
Event timing, post-discontinuation/long-term observation and exposure changes are unverified.
Required materials and conditions
12-week exposure, event/follow-up times and longer-term scope
Materials to obtain first
Harm/exposure timing and follow-up information
Further research
Research distinguishing timing and delayed harms
Remaining uncertainty
Event timing, post-discontinuation/long-term observation and exposure changes are unverified.
Conditions for verification
Separate original information about 12-week exposure, event/follow-up times and longer-term scope from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: What were harm timing and post-study/delayed follow-up?
Application exceptions
Do not turn 12-week symptom observation into completed long-term safety verification.
Referenced methods
M19 §19.2 design-specific harm questions; temporal-relationship details are internally designed; M19 §19.1.2–19.2.4; internal application

Related sources R01

N36 · How do shared yogurt, baseline/infection exposures and harm relatedness connect?

Current findings
The original compares identical yogurt with and without LG2055. Actual adjudication attributing harms/similar symptoms to the strain, shared drink, infection or other causes is absent.
Verification status
Unverified
Materials actually read
Summary read; external materials unread, access not attempted
Why unverified
The needed direct information was not verified within the current summary and unread-external-material scope. Medical history/drugs, exposures, actual events/relatedness and alternative causes are unverified.
Reason for missing information
Medical history/drugs, exposures, actual events/relatedness and alternative causes are unverified.
Required materials and conditions
LG2055/shared ingredients, concurrent drugs/illnesses and alternative causes
Materials to obtain first
History/concurrent exposures and event/cause-adjudication information
Further research
A plan distinguishing the exposure of interest from alternative causes
Remaining uncertainty
Medical history/drugs, exposures, actual events/relatedness and alternative causes are unverified.
Conditions for verification
Separate original information about LG2055/shared ingredients, concurrent drugs/illnesses and alternative causes from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: How do shared yogurt, baseline/infection exposures and harm relatedness connect?
Application exceptions
Do not establish symptoms as outcomes of a specific pathogen or drink-related harm, or add cold-management/treatment instructions.
Referenced methods
Design considerations in M19 §19.2.2–19.2.4; Detailed confounding records are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; Internal application; M08 Table 8.2.a, M03 §3.2.4; Internal application

Related sources R01

N37 · Are completion/exclusion and missing diaries distinguished from harm-related discontinuation?

Current findings
Original completion/exclusion counts are preserved, but harm/protocol/diary reasons and harm collection in omitted participants are not detailed.
Verification status
Unverified
Materials actually read
Summary read; external materials unread, access not attempted
Why unverified
The needed direct information was not verified within the current summary and unread-external-material scope. Arm-specific exclusions/discontinuations/missingness, their harm relationships and collection/handling are unverified.
Reason for missing information
Arm-specific exclusions/discontinuations/missingness, their harm relationships and collection/handling are unverified.
Required materials and conditions
Original 198 completers/5 exclusions, PPS and harm/missingness reasons
Materials to obtain first
Participant/diary flow, exclusions/harm-related discontinuations and missing data
Further research
A plan separating missingness from harm-related discontinuation
Remaining uncertainty
Arm-specific exclusions/discontinuations/missingness, their harm relationships and collection/handling are unverified.
Conditions for verification
Separate original information about Original 198 completers/5 exclusions, PPS and harm/missingness reasons from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: Are completion/exclusion and missing diaries distinguished from harm-related discontinuation?
Application exceptions
Do not convert the original 5 exclusions into people with adverse effects or calculate a new randomized/completer difference.
Referenced methods
M19 §19.1.2–19.2.4, M04 §4.6.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application

Related sources R01

N38 · How are independent harm data distinguished from observations in the same trial?

Current findings
The current listing is this symptom-day efficacy report. Separate original harm data were not searched for or acquired in this run; the same report, arms, person-days and siblings are not counted as independent harm trials.
Verification status
Unverified
Materials actually read
Summary read; external materials unread, access not attempted
Why unverified
The needed direct information was not verified within the current summary and unread-external-material scope. Independent harm-report identities, populations/exposures and overlap are unverified.
Reason for missing information
Independent harm-report identities, populations/exposures and overlap are unverified.
Required materials and conditions
Separate safety-report identities, exposures/populations and overlap
Materials to obtain first
Separate harm/surveillance and event information
Further research
Independent safety research with clear populations/exposures
Remaining uncertainty
Independent harm-report identities, populations/exposures and overlap are unverified.
Conditions for verification
Separate original information about Separate safety-report identities, exposures/populations and overlap from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: How are independent harm data distinguished from observations in the same trial?
Application exceptions
No separate current slot does not establish the absence of all external harm reports.
Referenced methods
M04 §§4.6.1–4.6.2; harm-material adaptation is Chamgap-designed; M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations

Related sources R01

N39 · What is known about vulnerable populations, other illnesses/products and repeated/long-term safety?

Current findings
A 12-week drink study in healthy adults cannot establish safety for other illnesses/ages, immune states, products or repeated/long-term exposures.
Verification status
Unverified
Materials actually read
Summary read; external materials unread, access not attempted
Why unverified
The needed direct information was not verified within the current summary and unread-external-material scope. Vulnerable populations/concurrent medication, direct events and long-term/repeated-exposure data are unverified.
Reason for missing information
Vulnerable populations/concurrent medication, direct events and long-term/repeated-exposure data are unverified.
Required materials and conditions
Healthy adults versus allergy/illness and long-term scope
Materials to obtain first
Direct harm data by population and exposure duration
Further research
Research separating population and long-term safety questions
Remaining uncertainty
Vulnerable populations/concurrent medication, direct events and long-term/repeated-exposure data are unverified.
Conditions for verification
Separate original information about Healthy adults versus allergy/illness and long-term scope from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: What is known about vulnerable populations, other illnesses/products and repeated/long-term safety?
Application exceptions
Do not propose implementation instructions for probiotic/product intake, cold management/prevention or treatment substitution.
Referenced methods
M19 §19.1.2–19.2.4; Internal application; Design considerations in M19 §19.2.2–19.2.4; Detailed confounding records are internally designed

Related sources R01

N40 · Are the causal scopes of symptom-day benefit, infection gaps and the original good safety status distinguished?

Current findings
Fewer symptom-days, unmeasured laboratory-confirmed infections, no reported serious related signals and the parent's good safety status are preserved separately. Symptom-day benefit does not certify infection prevention, improved immunity or safety.
Verification status
Partly verified
Materials actually read
Summary read; external materials unread, access not attempted
Why unverified
Some original summary information was linked for production; clinical verification/review is incomplete. Direct confirmed-infection/comparative-harm data, causality and long-term precision are unverified.
Reason for missing information
Direct confirmed-infection/comparative-harm data, causality and long-term precision are unverified.
Required materials and conditions
Different benefits/events, original safety and harm causality
Materials to obtain first
Direct infection and separate harm/follow-up data
Further research
A plan separating different outcomes and estimands
Remaining uncertainty
Direct confirmed-infection/comparative-harm data, causality and long-term precision are unverified.
Conditions for verification
Separate original information about Different benefits/events, original safety and harm causality from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: Are the causal scopes of symptom-day benefit, infection gaps and the original good safety status distinguished?
Application exceptions
Do not newly classify unmeasured infection as zero effect, established harm or guaranteed safety.
Referenced methods
Chamgap internal interpretation boundaries, informed by M19 principles without running an official causality tool; M03 §3.2.4; Internally defined extrapolation boundaries

Related sources R01

N41 · How are follow-up materials, historical candidates/versions and incomplete prior content review connected?

Current findings
Criteria are saved and frozen before separate application. Prior candidate pending/eligible states remain history. Current content/boundary review is incomplete; completion is false, new units are 0 and final independent counts remain unrecorded.
Verification status
Partly verified
Materials actually read
Summary read; external materials unread, access not attempted
Why unverified
Some original summary information was linked for production; clinical verification/review is incomplete. No follow-up original materials, actual reading, changes or content-review/independence decisions yet exist.
Reason for missing information
No follow-up original materials, actual reading, changes or content-review/independence decisions yet exist.
Required materials and conditions
Review summary/criteria, original values/units, new materials and user decisions
Materials to obtain first
Additional original materials, before/after values, versions and user-decision records
Further research
Research addressing direct gaps in confirmed-infection incidence
Remaining uncertainty
No follow-up original materials, actual reading, changes or content-review/independence decisions yet exist.
Conditions for verification
Separate original information about Review summary/criteria, original values/units, new materials and user decisions from unverified information and boundaries for symptom-days, infection, harms and longer-term extrapolation.
Why this condition is needed
Needed to distinguish the original drink/population, people/days/events and unverified scope for: How are follow-up materials, historical candidates/versions and incomplete prior content review connected?
Application exceptions
Do not invent current model/clinical review or completed publication from historical cross-checks or completed production.
Referenced methods
M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed splitting rules are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M04 §4.5, §4.6.3; current material-conversion limits follow review scope and internal design; M08 Table 8.2.a, M04 §4.6.3; internal application

Related sources R01