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

Verdict 2977 · Evidence Check

Stored-material review date: Not recorded  
Original evidence cut-off: 2026-08-26  
Review-criteria version: 1.0  
Public page/material preparation date: 2026-10-14

Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect.

## Assessment scope

- 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

## Checklist items

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

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- 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.
- 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
- 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.
- Remaining uncertainty: No new direct trial or clinical independence has been certified for the selected infection outcome.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- 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.
- 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
- 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.
- Remaining uncertainty: Subclaim score/status/axes are absent in the original.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- 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.
- 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
- 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.
- Remaining uncertainty: Cold susceptibility, baseline history, sex/severity and inclusion/exclusion criteria are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- 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.
- 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
- 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.
- Remaining uncertainty: Organism count, manufacture/storage, composition and actual product/quality specifications are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- 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.
- 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
- 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.
- Remaining uncertainty: Equivalence/sensory properties, shared composition and actual exposure/adherence are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- 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.
- 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
- 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.
- Remaining uncertainty: Amount/frequency, actual adherence, missed/contaminating exposure and storage conditions are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- 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.
- 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
- 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.
- Remaining uncertainty: Exact visit/observation windows, discontinuation/post-study observations and infection-event follow-up are unverified.
- 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?

Verification status: Unverified  
Reading scope: Summary read; external materials unread, access not attempted

- 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.
- 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
- 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.
- Remaining uncertainty: Pathogens/testing, confirmed events/denominators and direct comparative effects/CIs are unverified.
- 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?

Verification status: Unverified  
Reading scope: Summary read; external materials unread, access not attempted

- 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.
- 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
- 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.
- Remaining uncertainty: Clinician adjudication, testing/pathogens, positivity criteria and event timing are unverified.
- 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?

Verification status: Unverified  
Reading scope: Summary read; external materials unread, access not attempted

- 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.
- 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
- 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.
- Remaining uncertainty: Infected people/events, incidence, time/denominators and effects of interest/CIs are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- 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.
- 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
- 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.
- Remaining uncertainty: Exact observation-day definitions, repeated/missing-data handling, denominator aggregation and CIs are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- 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.
- 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
- 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.
- Remaining uncertainty: Symptom-specific numerators/denominators, CIs, definitions/hierarchy and multiplicity are unverified.
- 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?

Verification status: Unverified  
Reading scope: Summary read; external materials unread, access not attempted

- 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.
- 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
- 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.
- Remaining uncertainty: Within-person correlation, concurrent symptoms, aggregation/models and each person's observation duration are unverified.
- 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?

Verification status: Unverified  
Reading scope: Summary read; external materials unread, access not attempted

- 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.
- 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
- 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.
- Remaining uncertainty: Missingness/nonresponse, aggregation/imputation, individual day counts and infection data are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- 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.
- 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
- 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.
- Remaining uncertainty: Prespecified lists/hierarchy, multiplicity, success criteria and secondary analyses are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- 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.
- 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
- 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.
- Remaining uncertainty: Actual registry versions, amendment/public/start details and original prespecified plans remain unread.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- 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.
- 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
- 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.
- Remaining uncertainty: Allocation/concealment, baseline balance and blinding/sensory/awareness procedures are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- 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.
- 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
- 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.
- Remaining uncertainty: Arm-specific completion/exclusion reasons, detailed PPS 97/96 mapping and endpoint denominators are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- 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.
- 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
- 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.
- Remaining uncertainty: PPS selection, analysis models, ITT/imputation, sensitivity and missingness/attrition reasons are unverified.
- 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?

Verification status: Unverified  
Reading scope: Summary read; external materials unread, access not attempted

- 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.
- 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
- 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.
- Remaining uncertainty: Baseline/changed medication, lifestyle/infection exposure, shared support and arm differences are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- 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.
- 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
- 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.
- Remaining uncertainty: Diary/assessment methods, symptom thresholds, confirmation/classification and severity procedures are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- 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.
- 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
- 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.
- Remaining uncertainty: Symptom-day models/intervals, repeated correlation, direct infection effects/intervals and clinical importance are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- 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.
- 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
- 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.
- Remaining uncertainty: Individual/period-specific data, baseline/adjustment, estimands and infection-event definitions are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- 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.
- 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
- 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.
- Remaining uncertainty: Current details of original disclosures/support and design/analysis/data-access roles remain unread.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- 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.
- 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
- 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.
- Remaining uncertainty: Related report/trial relationships and unique trial/participant totals are unverified.
- 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?

Verification status: Unverified  
Reading scope: Summary read; external materials unread, access not attempted

- 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.
- 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
- 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.
- Remaining uncertainty: Direct confirmed-infection reports, populations/strains/testing and overlap/independence are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- 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.
- 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
- 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.
- Remaining uncertainty: Direct effects, CIs and interactions by population, strain, product and setting are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- 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.
- 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
- 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.
- Remaining uncertainty: Direct infection and patient-important/clinical events, effects, denominators and CIs are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- Current findings: The original observation concerns 12-week symptom-days. Persistence after discontinuation, repeated/longer use and long-term confirmed-infection outcomes are absent.
- 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
- 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.
- Remaining uncertainty: Direct post-study/long-term benefits/harms, denominators and CIs are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- 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.
- 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
- 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.
- Remaining uncertainty: Current external-method/result and registry/planning details remain unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- 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.
- 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
- 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.
- Remaining uncertainty: External detailed translation, registry/original-text and correction comparisons were not performed in this run.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- 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.
- 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
- 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.
- Remaining uncertainty: Harm collection, all/serious events, relatedness and discontinuation tables are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- 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.
- 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
- 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.
- Remaining uncertainty: Population selection, actual events/denominators, severity and relatedness are unverified.
- 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?

Verification status: Unverified  
Reading scope: Summary read; external materials unread, access not attempted

- 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.
- 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
- 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.
- Remaining uncertainty: Arm/period-specific collection, events/exposure denominators and comparative effects/CIs are unverified.
- 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?

Verification status: Unverified  
Reading scope: Summary read; external materials unread, access not attempted

- Current findings: The original has a 12-week safety narrative but no separate event timing, period-specific observation or post-study/delayed-harm data.
- 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
- 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.
- Remaining uncertainty: Event timing, post-discontinuation/long-term observation and exposure changes are unverified.
- 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?

Verification status: Unverified  
Reading scope: Summary read; external materials unread, access not attempted

- 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.
- 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
- 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.
- Remaining uncertainty: Medical history/drugs, exposures, actual events/relatedness and alternative causes are unverified.
- 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?

Verification status: Unverified  
Reading scope: Summary read; external materials unread, access not attempted

- Current findings: Original completion/exclusion counts are preserved, but harm/protocol/diary reasons and harm collection in omitted participants are not detailed.
- 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
- 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.
- Remaining uncertainty: Arm-specific exclusions/discontinuations/missingness, their harm relationships and collection/handling are unverified.
- 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?

Verification status: Unverified  
Reading scope: Summary read; external materials unread, access not attempted

- 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.
- 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
- 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.
- Remaining uncertainty: Independent harm-report identities, populations/exposures and overlap are unverified.
- 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?

Verification status: Unverified  
Reading scope: Summary read; external materials unread, access not attempted

- 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.
- 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
- 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.
- Remaining uncertainty: Vulnerable populations/concurrent medication, direct events and long-term/repeated-exposure data are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- 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.
- 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
- 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.
- Remaining uncertainty: Direct confirmed-infection/comparative-harm data, causality and long-term precision are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- 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.
- 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
- 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.
- Remaining uncertainty: No follow-up original materials, actual reading, changes or content-review/independence decisions yet exist.
- 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

## Evidence and sources

### 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](https://pubmed.ncbi.nlm.nih.gov/36570128/)

Materials actually read: Summary read; external materials unread, access not attempted  
Findings recorded in the 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.  
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.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| Stored summary | Local preserved summary | Summary read | Summary read | Only acquisition/reading of the complete parent summary is established, not original confirmed-infection research, paper or registry acquisition. |
| Abstract | External materials unread/needed | Unread; access not attempted | Not read | Only the original citation link is connected. External access, content verification and link testing were not attempted. |
| Full paper | External materials unread/needed | Unread; access not attempted | Not read | The original bibliography supplies no DOI/PMCID. No original full text or external content was newly acquired/read. |
| Registration material | External materials unread/needed | Unread; access not attempted | Not read | Original UMIN000045901 and historical public/planned-start narrative are preserved. It is not NCT. External versions/content remain unread. |
| Protocol | External materials unread/needed | Unread; access not attempted | Not read | Original plans for identical yogurt/exposure, questionnaire/infection definitions, primary/secondary outcomes and harms are needed. Public availability/existence is unverified. |
| Statistical analysis plan | External materials unread/needed | Unread; access not attempted | Not read | Original plans for PPS/randomization, people/observation days, repetition/missingness, symptoms/composites and multiplicity are needed. |
| Outcome tables and questionnaire-day/infection/denominator/harm data | External materials unread/needed | Unread; access not attempted | Not read | Symptom-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 disclosures | External materials unread/needed | Unread; access not attempted | Not read | Original disclosures on company development/employees, KSO contracting and support roles remain unread. |

## Review criteria and methods

These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score.

- M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · 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/materials 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.