{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2977-s1", "verdict_number": "2977", "title": "LG2055 drinkable yogurt × Gaps in direct evidence for fewer cold infections", "view_version": "1.0", "view_created_date": "2026-10-14", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-08-26", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "The whole stored parent-verdict summary and selected subclaim were read for production. External papers, abstracts, full texts, registry, protocol, SAP and funding disclosures were not separately read or accessed. Historical review records are not inherited as current clinical verification or a new verdict.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "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.", "intervention": "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.", "endpoint": "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.", "excluded_extensions": [ "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" ] }, "requirements": [ { "item_id": "N01", "question_type": "Scope and evidence gaps for infection incidence versus symptom-days", "question": "How is the selected infection-incidence question distinguished from the symptom-day sheet?", "needed": "Infection-incidence question and verdict linkage versus the parent and symptom-day endpoints", "role": "Required", "role_reason": "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_exception": "Do not transfer the sibling C grade or positive symptom-day findings into direct evidence or a grade for infection incidence.", "criterion": "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.", "basis": "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", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "A prespecified research question distinguishing symptom-days from confirmed infection events", "current_reports": [ "R01" ], "existence": "A preserved symptom-day trial summary exists; direct confirmed-infection and external details remain unread/needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "No new direct trial or clinical independence has been certified for the selected infection outcome.", "uncertainty": "No new direct trial or clinical independence has been certified for the selected infection outcome.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original question, symptom/infection definitions and population/comparator information" }, { "item_id": "N02", "question_type": "Scope and evidence gaps for infection incidence versus symptom-days", "question": "What are the selected grade/note and the absent score, status and axes?", "needed": "Subclaim ? grade/note, absent score/status/axes and parent history", "role": "Required", "role_reason": "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_exception": "Do not fill subclaim values or claim a current review pass using the parent score of 50 or symptom-endpoint P/E+ axes.", "criterion": "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.", "basis": "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", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Separate preservation of the original grade from updates with additional evidence", "current_reports": [ "R01" ], "existence": "A preserved symptom-day trial summary exists; direct confirmed-infection and external details remain unread/needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "Some original summary information was linked for production; clinical verification/review is incomplete. The original subclaim lacks a score, status and axes.", "missingness": "Subclaim score/status/axes are absent in the original.", "uncertainty": "Subclaim score/status/axes are absent in the original.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original subclaim and an explicit change event" }, { "item_id": "N03", "question_type": "Scope and evidence gaps for infection incidence versus symptom-days", "question": "Who were the actual participants, and how was susceptibility to colds defined?", "needed": "Recruitment of healthy Japanese adults aged 20–64 who were prone to colds", "role": "Required", "role_reason": "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_exception": "Do not extend healthy-adult findings to infection prevention for all ages, illnesses or immunocompromised people.", "criterion": "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.", "basis": "M03 §3.2.1; detailed population conditions are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Research specifying the population and infection/symptom definitions", "current_reports": [ "R01" ], "existence": "A preserved symptom-day trial summary exists; direct confirmed-infection and external details remain unread/needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Cold susceptibility, baseline history, sex/severity and inclusion/exclusion criteria are unverified.", "uncertainty": "Cold susceptibility, baseline history, sex/severity and inclusion/exclusion criteria are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Eligibility criteria and baseline characteristics/history" }, { "item_id": "N04", "question_type": "Scope and evidence gaps for infection incidence versus symptom-days", "question": "What are the identities of the LG2055 study drink and strain?", "needed": "LG2055 drinkable yogurt and the original strain name", "role": "Required", "role_reason": "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_exception": "Do not generalize an isolated effect to generic probiotics or other strains/products, or arbitrarily rename the strain.", "criterion": "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.", "basis": "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", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Research specifying the exact study drink and strain", "current_reports": [ "R01" ], "existence": "A preserved symptom-day trial summary exists; direct confirmed-infection and external details remain unread/needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Organism count, manufacture/storage, composition and actual product/quality specifications are unverified.", "uncertainty": "Organism count, manufacture/storage, composition and actual product/quality specifications are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Study-drink, strain, quality and exposure specifications" }, { "item_id": "N05", "question_type": "Scope and evidence gaps for infection incidence versus symptom-days", "question": "What were the control yogurt and comparison of interest?", "needed": "Identical yogurt with only LG2055 removed and the shared ingredients", "role": "Required", "role_reason": "Needed to distinguish the original drink/population, people/days/events and unverified scope for: What were the control yogurt and comparison of interest?", "application_exception": "Do not transfer symptom-day results into infection prevention by yogurt as a whole or an isolated LG2055 effect on confirmed infections.", "criterion": "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.", "basis": "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", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Research specifying the contrast on an identical-yogurt background", "current_reports": [ "R01" ], "existence": "A preserved symptom-day trial summary exists; direct confirmed-infection and external details remain unread/needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "Some original summary information was linked for production; clinical verification/review is incomplete. Equivalence/sensory properties, shared composition and actual exposure/adherence are unverified.", "missingness": "Equivalence/sensory properties, shared composition and actual exposure/adherence are unverified.", "uncertainty": "Equivalence/sensory properties, shared composition and actual exposure/adherence are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Active/control specifications and shared-exposure/blinding information" }, { "item_id": "N06", "question_type": "Scope and evidence gaps for infection incidence versus symptom-days", "question": "What were the intake amount, organism count, frequency and actual adherence?", "needed": "Target/actual study-drink exposure, adherence and deviations", "role": "Required", "role_reason": "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_exception": "Do not create intake amounts, dosing instructions or organism-count conversions for probiotics, drinks or products.", "criterion": "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.", "basis": "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", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "A plan separating intended provision from actual exposure", "current_reports": [ "R01" ], "existence": "A preserved symptom-day trial summary exists; direct confirmed-infection and external details remain unread/needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Amount/frequency, actual adherence, missed/contaminating exposure and storage conditions are unverified.", "uncertainty": "Amount/frequency, actual adherence, missed/contaminating exposure and storage conditions are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Study exposure/provision and adherence records" }, { "item_id": "N07", "question_type": "Scope and evidence gaps for infection incidence versus symptom-days", "question": "What were the 12-week winter observation, follow-up timing and longer-term scope?", "needed": "Winter observation, 12 weeks, time points and post-study outcomes", "role": "Required", "role_reason": "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_exception": "Do not turn 12-week symptom observation into continuous infection prevention or effects across an entire season or the long term.", "criterion": "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.", "basis": "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", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "A plan distinguishing duration and symptom/infection outcomes", "current_reports": [ "R01" ], "existence": "A preserved symptom-day trial summary exists; direct confirmed-infection and external details remain unread/needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Exact visit/observation windows, discontinuation/post-study observations and infection-event follow-up are unverified.", "uncertainty": "Exact visit/observation windows, discontinuation/post-study observations and infection-event follow-up are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Schedules/questionnaires and exposure/follow-up information" }, { "item_id": "N08", "question_type": "Scope and evidence gaps for infection incidence versus symptom-days", "question": "Was laboratory-confirmed infection incidence actually measured?", "needed": "Pathogen-confirmed infection events and testing/diagnostic definitions", "role": "Required", "role_reason": "Needed to distinguish the original drink/population, people/days/events and unverified scope for: Was laboratory-confirmed infection incidence actually measured?", "application_exception": "Preserve the original statement of nonmeasurement without newly judging infection incidence or effects as zero, or prevention as successful.", "criterion": "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.", "basis": "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", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Research defining symptom questionnaires and confirmed infection events separately", "current_reports": [ "R01" ], "existence": "A preserved symptom-day trial summary exists; direct confirmed-infection and external details remain unread/needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Pathogens/testing, confirmed events/denominators and direct comparative effects/CIs are unverified.", "uncertainty": "Pathogens/testing, confirmed events/denominators and direct comparative effects/CIs are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Research directly measuring confirmed infections, with test/event definitions" }, { "item_id": "N09", "question_type": "Scope and evidence gaps for infection incidence versus symptom-days", "question": "What was the scope of clinician confirmation, pathogen types and testing times?", "needed": "Clinician/test confirmation, pathogens/timing and the distinction from similar symptoms", "role": "Required", "role_reason": "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_exception": "Do not invent clinician adjudication or testing absent from the summary, or attribute symptoms to a particular infection.", "criterion": "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.", "basis": "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", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Research defining confirmation methods, pathogens and observation times", "current_reports": [ "R01" ], "existence": "A preserved symptom-day trial summary exists; direct confirmed-infection and external details remain unread/needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Clinician adjudication, testing/pathogens, positivity criteria and event timing are unverified.", "uncertainty": "Clinician adjudication, testing/pathogens, positivity criteria and event timing are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Clinician/test-confirmed infections and original adjudication/testing information" }, { "item_id": "N10", "question_type": "Scope and evidence gaps for infection incidence versus symptom-days", "question": "Are there infected-person counts, first/recurrent events and incidence denominators?", "needed": "People/events, time at risk, reinfections/repeats and denominators", "role": "Required", "role_reason": "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_exception": "Do not convert symptom-day proportions into proportions of infected people, infection-event counts or incidence.", "criterion": "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.", "basis": "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", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Research distinguishing first/recurrent events and person/time denominators", "current_reports": [ "R01" ], "existence": "A preserved symptom-day trial summary exists; direct confirmed-infection and external details remain unread/needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Infected people/events, incidence, time/denominators and effects of interest/CIs are unverified.", "uncertainty": "Infected people/events, incidence, time/denominators and effects of interest/CIs are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Infection-event/person flow, time at risk and direct results" }, { "item_id": "N11", "question_type": "Scope and evidence gaps for infection incidence versus symptom-days", "question": "What units underlie the original runny-nose numerators, denominators and absolute difference?", "needed": "2,384/8,148 days versus 2,769/8,066 days, proportions and the original difference", "role": "Supplementary", "role_reason": "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_exception": "Do not recalculate the original −5.0 percentage points or convert it into infection risk differences, RR/NNT or individual prevention probabilities.", "criterion": "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.", "basis": "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", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "A plan distinguishing estimands for people, observation days and symptom-days", "current_reports": [ "R01" ], "existence": "A preserved symptom-day trial summary exists; direct confirmed-infection and external details remain unread/needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Exact observation-day definitions, repeated/missing-data handling, denominator aggregation and CIs are unverified.", "uncertainty": "Exact observation-day definitions, repeated/missing-data handling, denominator aggregation and CIs are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Questionnaire/aggregation definitions, original daily data and denominator/analysis tables" }, { "item_id": "N12", "question_type": "Scope and evidence gaps for infection incidence versus symptom-days", "question": "What do the other symptom proportions and cough P value mean?", "needed": "Original symptom-days for nasal congestion, sneezing, sore throat, hoarseness and cough", "role": "Supplementary", "role_reason": "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_exception": "Do not combine symptoms or time points into new confirmed-infection counts or a composite success score.", "criterion": "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.", "basis": "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", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Research specifying symptom-specific outcomes and the planned hierarchy", "current_reports": [ "R01" ], "existence": "A preserved symptom-day trial summary exists; direct confirmed-infection and external details remain unread/needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "Some original summary information was linked for production; clinical verification/review is incomplete. Symptom-specific numerators/denominators, CIs, definitions/hierarchy and multiplicity are unverified.", "missingness": "Symptom-specific numerators/denominators, CIs, definitions/hierarchy and multiplicity are unverified.", "uncertainty": "Symptom-specific numerators/denominators, CIs, definitions/hierarchy and multiplicity are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Each symptom's definition, denominator, analysis and plan" }, { "item_id": "N13", "question_type": "Scope and evidence gaps for infection incidence versus symptom-days", "question": "What are the analysis units for people, observation days, symptoms and repeated records?", "needed": "Repeated diaries from the same people, symptoms/groups/times and correlation", "role": "Required", "role_reason": "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_exception": "Do not reanalyze all observation days as independent binary observations or inflate the sample size.", "criterion": "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.", "basis": "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", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Research distinguishing people, repeated records and events", "current_reports": [ "R01" ], "existence": "A preserved symptom-day trial summary exists; direct confirmed-infection and external details remain unread/needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Within-person correlation, concurrent symptoms, aggregation/models and each person's observation duration are unverified.", "uncertainty": "Within-person correlation, concurrent symptoms, aggregation/models and each person's observation duration are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Individual diaries and denominator/repeated-measures analysis plans" }, { "item_id": "N14", "question_type": "Scope and evidence gaps for infection incidence versus symptom-days", "question": "Are questionnaire missingness, recording adherence and unmeasured infections distinguished?", "needed": "Missing diaries/symptoms, unmeasured infections and imputation/denominators", "role": "Required", "role_reason": "Needed to distinguish the original drink/population, people/days/events and unverified scope for: Are questionnaire missingness, recording adherence and unmeasured infections distinguished?", "application_exception": "Do not fill missing days as symptom-free/infection-free or treat unmeasured infection as a zero effect.", "criterion": "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.", "basis": "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", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "A plan distinguishing missing records from unmeasured infection events", "current_reports": [ "R01" ], "existence": "A preserved symptom-day trial summary exists; direct confirmed-infection and external details remain unread/needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Missingness/nonresponse, aggregation/imputation, individual day counts and infection data are unverified.", "uncertainty": "Missingness/nonresponse, aggregation/imputation, individual day counts and infection data are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Questionnaire adherence/missingness, denominator rules and SAP" }, { "item_id": "N15", "question_type": "Scope and evidence gaps for infection incidence versus symptom-days", "question": "What were the prespecified primary, symptom-specific/secondary and composite outcomes and multiplicity rules?", "needed": "Original primary symptom-days, hierarchical composite and secondary hierarchy", "role": "Required", "role_reason": "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_exception": "Do not establish overall infection-prevention efficacy or a new composite outcome from one selected positive symptom.", "criterion": "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.", "basis": "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", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Research prespecifying symptom/infection and primary/secondary estimands", "current_reports": [ "R01" ], "existence": "A preserved symptom-day trial summary exists; direct confirmed-infection and external details remain unread/needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "Some original summary information was linked for production; clinical verification/review is incomplete. Prespecified lists/hierarchy, multiplicity, success criteria and secondary analyses are unverified.", "missingness": "Prespecified lists/hierarchy, multiplicity, success criteria and secondary analyses are unverified.", "uncertainty": "Prespecified lists/hierarchy, multiplicity, success criteria and secondary analyses are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Registry/protocol/SAP and the complete outcome list" }, { "item_id": "N16", "question_type": "Scope and evidence gaps for infection incidence versus symptom-days", "question": "What was the original discrepancy between the registry ID, claimed preregistration and public date?", "needed": "UMIN000045901, original planned-start/public dates and unread external records", "role": "Required", "role_reason": "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_exception": "Do not replace UMIN with NCT, calculate the date gap or upgrade it to a current registry-review pass.", "criterion": "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.", "basis": "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", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Records separating plans from publication/amendment events", "current_reports": [ "R01" ], "existence": "A preserved symptom-day trial summary exists; direct confirmed-infection and external details remain unread/needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Actual registry versions, amendment/public/start details and original prespecified plans remain unread.", "uncertainty": "Actual registry versions, amendment/public/start details and original prespecified plans remain unread.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Registry versions/timing, protocol/SAP and comparison with the original paper" }, { "item_id": "N17", "question_type": "Scope and evidence gaps for infection incidence versus symptom-days", "question": "What were the actual randomization, identical-yogurt and double-blinding procedures?", "needed": "Allocation/concealment, baseline balance, blinding and awareness of conditions", "role": "Required", "role_reason": "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_exception": "Do not certify successful blinding, absence of bias or independence from the original design label or B1 axis.", "criterion": "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.", "basis": "M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "An allocation/blinding plan for identical yogurt", "current_reports": [ "R01" ], "existence": "A preserved symptom-day trial summary exists; direct confirmed-infection and external details remain unread/needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "Some original summary information was linked for production; clinical verification/review is incomplete. Allocation/concealment, baseline balance and blinding/sensory/awareness procedures are unverified.", "missingness": "Allocation/concealment, baseline balance and blinding/sensory/awareness procedures are unverified.", "uncertainty": "Allocation/concealment, baseline balance and blinding/sensory/awareness procedures are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Allocation/blinding and baseline/equivalence tables" }, { "item_id": "N18", "question_type": "Scope and evidence gaps for infection incidence versus symptom-days", "question": "What were the original randomized, intake-completer, exclusion and PPS counts?", "needed": "200, 100 per arm, 198 completers, original 5 exclusions and 193 (97/96)", "role": "Required", "role_reason": "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_exception": "Do not calculate or add new dropout/exclusion counts or proportions from 200/198/193.", "criterion": "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.", "basis": "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", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "A plan distinguishing randomized, completer and analysis populations", "current_reports": [ "R01" ], "existence": "A preserved symptom-day trial summary exists; direct confirmed-infection and external details remain unread/needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Arm-specific completion/exclusion reasons, detailed PPS 97/96 mapping and endpoint denominators are unverified.", "uncertainty": "Arm-specific completion/exclusion reasons, detailed PPS 97/96 mapping and endpoint denominators are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Participant flow, arm/endpoint denominators and PPS definition" }, { "item_id": "N19", "question_type": "Scope and evidence gaps for infection incidence versus symptom-days", "question": "What were the PPS, completer, ITT and other analysis populations and missing-data handling?", "needed": "Original primary-efficacy PPS versus the estimand for all randomized participants", "role": "Required", "role_reason": "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_exception": "Do not replicate symptom-day PPS findings as direct effects for all randomized people or confirmed-infection populations.", "criterion": "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.", "basis": "M08 §8.2.2, M15 §15.3.1; Internal application; M08 Table 8.2.a, M04 §4.6.3; Internal application", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Research prespecifying assignment/adherence effects and missingness", "current_reports": [ "R01" ], "existence": "A preserved symptom-day trial summary exists; direct confirmed-infection and external details remain unread/needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "PPS selection, analysis models, ITT/imputation, sensitivity and missingness/attrition reasons are unverified.", "uncertainty": "PPS selection, analysis models, ITT/imputation, sensitivity and missingness/attrition reasons are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "SAP, analysis populations/flow and missing-data results" }, { "item_id": "N20", "question_type": "Scope and evidence gaps for infection incidence versus symptom-days", "question": "Were baseline infection risk and shared lifestyle/treatment exposures verified?", "needed": "Cold susceptibility, concurrent exposures/drugs, arm-specific risk and shared conditions", "role": "Required", "role_reason": "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_exception": "Do not add infection-prevention/treatment components absent from the original as actual trial exposures or instructions.", "criterion": "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.", "basis": "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", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Research specifying shared conditions and infection risk", "current_reports": [ "R01" ], "existence": "A preserved symptom-day trial summary exists; direct confirmed-infection and external details remain unread/needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Baseline/changed medication, lifestyle/infection exposure, shared support and arm differences are unverified.", "uncertainty": "Baseline/changed medication, lifestyle/infection exposure, shared support and arm differences are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Baseline/concurrent exposures, protocol and visit records" }, { "item_id": "N21", "question_type": "Scope and evidence gaps for infection incidence versus symptom-days", "question": "How were subjective questionnaires collected and adjudicated?", "needed": "Diaries, symptom definitions/severity and assessors versus testing", "role": "Required", "role_reason": "Needed to distinguish the original drink/population, people/days/events and unverified scope for: How were subjective questionnaires collected and adjudicated?", "application_exception": "Do not automatically classify symptomatic colds as clinician/test-confirmed diagnoses.", "criterion": "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.", "basis": "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", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "A measurement plan separating subjective symptoms from confirmed infection", "current_reports": [ "R01" ], "existence": "A preserved symptom-day trial summary exists; direct confirmed-infection and external details remain unread/needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The endpoint is days with questionnaire-recorded cold-like symptoms. Symptom criteria, recording frequency/severity, assessment/adjudication and links to testing are not detailed.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Diary/assessment methods, symptom thresholds, confirmation/classification and severity procedures are unverified.", "uncertainty": "Diary/assessment methods, symptom thresholds, confirmation/classification and severity procedures are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Questionnaire/diary forms, symptom definitions and collection/adjudication methods" }, { "item_id": "N22", "question_type": "Scope and evidence gaps for infection incidence versus symptom-days", "question": "What were the original unreported CIs, precision and missing direct infection estimates?", "needed": "Original symptom-day −5.0 percentage points/P, absent 95% CI and the infection-estimate gap", "role": "Required", "role_reason": "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_exception": "Do not calculate new CI/RR/NNT from aggregate days or transfer them into infection-effect estimates.", "criterion": "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.", "basis": "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", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Research specifying units, estimands and precision", "current_reports": [ "R01" ], "existence": "A preserved symptom-day trial summary exists; direct confirmed-infection and external details remain unread/needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Symptom-day models/intervals, repeated correlation, direct infection effects/intervals and clinical importance are unverified.", "uncertainty": "Symptom-day models/intervals, repeated correlation, direct infection effects/intervals and clinical importance are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Analysis results/SAP and direct infection data" }, { "item_id": "N23", "question_type": "Scope and evidence gaps for infection incidence versus symptom-days", "question": "Are within/between-group symptom-days, periods and event estimands distinguished?", "needed": "Original day-proportion contrast versus individuals/infection, adjustment and models", "role": "Required", "role_reason": "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_exception": "Do not interpret aggregate proportions as reduced individual infection risk or guaranteed prevention.", "criterion": "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.", "basis": "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", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Research separating symptom-days, people/events and within/between-group contrasts", "current_reports": [ "R01" ], "existence": "A preserved symptom-day trial summary exists; direct confirmed-infection and external details remain unread/needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Individual/period-specific data, baseline/adjustment, estimands and infection-event definitions are unverified.", "uncertainty": "Individual/period-specific data, baseline/adjustment, estimands and infection-event definitions are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Individual/aggregate results, estimands/models and direct infection data" }, { "item_id": "N24", "question_type": "Scope and evidence gaps for infection incidence versus symptom-days", "question": "What were the original sponsor, employee/contractor and product-development details?", "needed": "Four MEGMILK employees, a KSO employee and product/support scope", "role": "Required", "role_reason": "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_exception": "Do not add the contractor employee to the four company employees or regrade original values solely because of sponsorship.", "criterion": "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.", "basis": "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", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Explicit support and research-decision/analysis roles", "current_reports": [ "R01" ], "existence": "A preserved symptom-day trial summary exists; direct confirmed-infection and external details remain unread/needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Current details of original disclosures/support and design/analysis/data-access roles remain unread.", "uncertainty": "Current details of original disclosures/support and design/analysis/data-access roles remain unread.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original support/product-provision, author/contractor-role and disclosure records" }, { "item_id": "N25", "question_type": "Scope and evidence gaps for infection incidence versus symptom-days", "question": "Are reports/trials, symptoms/person-days and sibling sheets linked to the same family?", "needed": "Kobatake 2022 citation and relationships within the same population/observations", "role": "Required", "role_reason": "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_exception": "One report slot does not certify one direct confirmed-infection trial or a final clinically independent count.", "criterion": "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.", "basis": "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", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Records distinguishing reports from study families", "current_reports": [ "R01" ], "existence": "A preserved symptom-day trial summary exists; direct confirmed-infection and external details remain unread/needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "Some original summary information was linked for production; clinical verification/review is incomplete. Related report/trial relationships and unique trial/participant totals are unverified.", "missingness": "Related report/trial relationships and unique trial/participant totals are unverified.", "uncertainty": "Related report/trial relationships and unique trial/participant totals are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial/related-report identities and observation-unit information" }, { "item_id": "N26", "question_type": "Scope and evidence gaps for infection incidence versus symptom-days", "question": "Is there direct replication or independent confirmation for confirmed infection?", "needed": "Direct trials of the selected infection incidence, confirmation methods and identities", "role": "Required", "role_reason": "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_exception": "Do not count sibling symptom reports as independent infection trials or extend the original single trial into a current worldwide absence-of-research finding.", "criterion": "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.", "basis": "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", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Separate research defining confirmed-infection events", "current_reports": [ "R01" ], "existence": "A preserved symptom-day trial summary exists; direct confirmed-infection and external details remain unread/needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Direct confirmed-infection reports, populations/strains/testing and overlap/independence are unverified.", "uncertainty": "Direct confirmed-infection reports, populations/strains/testing and overlap/independence are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct infection-confirmation/replication reports and trial identities" }, { "item_id": "N27", "question_type": "Scope and evidence gaps for infection incidence versus symptom-days", "question": "What is the applicability to other products/strains, populations and settings?", "needed": "Original LG2055 identical-yogurt/winter-adult context versus other scopes", "role": "Supplementary", "role_reason": "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_exception": "Do not extend findings into general immune improvement, prevention of all infections, product recommendations or intake instructions.", "criterion": "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.", "basis": "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", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Research prespecifying direct applicability", "current_reports": [ "R01" ], "existence": "A preserved symptom-day trial summary exists; direct confirmed-infection and external details remain unread/needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Direct effects, CIs and interactions by population, strain, product and setting are unverified.", "uncertainty": "Direct effects, CIs and interactions by population, strain, product and setting are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Exact formulation/population and confirmed-infection data" }, { "item_id": "N28", "question_type": "Scope and evidence gaps for infection incidence versus symptom-days", "question": "Are fewer symptom-days distinguished from infection prevention and important clinical outcomes?", "needed": "Questionnaire symptoms, confirmed infection and immune/serious clinical outcomes", "role": "Supplementary", "role_reason": "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_exception": "Do not turn positive symptom-day findings into laboratory-confirmed prevention, improved immunity or treatment substitution.", "criterion": "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.", "basis": "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", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "A plan separating symptom questions from confirmed-infection/clinical questions", "current_reports": [ "R01" ], "existence": "A preserved symptom-day trial summary exists; direct confirmed-infection and external details remain unread/needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Direct infection and patient-important/clinical events, effects, denominators and CIs are unverified.", "uncertainty": "Direct infection and patient-important/clinical events, effects, denominators and CIs are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct-event and patient-important-outcome information" }, { "item_id": "N29", "question_type": "Scope and evidence gaps for infection incidence versus symptom-days", "question": "What are persistence, repeated-use or prevention effects beyond 12 weeks?", "needed": "Exposure duration, after discontinuation and other/long-term infection outcomes", "role": "Supplementary", "role_reason": "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_exception": "Do not extend 12-week symptom findings into year-round prevention or long-term safety/intake schedules.", "criterion": "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.", "basis": "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", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Research distinguishing persistence/repetition questions from infection events", "current_reports": [ "R01" ], "existence": "A preserved symptom-day trial summary exists; direct confirmed-infection and external details remain unread/needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The original observation concerns 12-week symptom-days. Persistence after discontinuation, repeated/longer use and long-term confirmed-infection outcomes are absent.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Direct post-study/long-term benefits/harms, denominators and CIs are unverified.", "uncertainty": "Direct post-study/long-term benefits/harms, denominators and CIs are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Exposure/post-study and direct long-term results" }, { "item_id": "N30", "question_type": "Scope and evidence gaps for infection incidence versus symptom-days", "question": "What was read in the summary, what remains externally unread, and what do source links mean?", "needed": "Complete existing review summary, abstract/full text/registry and needed materials", "role": "Required", "role_reason": "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_exception": "Preserve absent DOI/PMCID fields in the original bibliography; do not declare external acquisition/reading or failed access based on an ID/URL.", "criterion": "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.", "basis": "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", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Records separating summary preservation from newly acquired materials", "current_reports": [ "R01" ], "existence": "A preserved symptom-day trial summary exists; direct confirmed-infection and external details remain unread/needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "Some original summary information was linked for production; clinical verification/review is incomplete. Current external-method/result and registry/planning details remain unverified.", "missingness": "Current external-method/result and registry/planning details remain unverified.", "uncertainty": "Current external-method/result and registry/planning details remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Acquired original materials and actual reading/additional events" }, { "item_id": "N31", "question_type": "Scope and evidence gaps for infection incidence versus symptom-days", "question": "What are the original bilingual text, dates/corrections, axes, absences and history?", "needed": "Languages, dates, empty values, parent C50/axes and original verdict narrative", "role": "Required", "role_reason": "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_exception": "Do not inherit the original 200-person rule, flaw scoring or cross-check narrative as current clinical review/rescoring, or invent absent fields.", "criterion": "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.", "basis": "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", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Separate original values/absences from new updates", "current_reports": [ "R01" ], "existence": "A preserved symptom-day trial summary exists; direct confirmed-infection and external details remain unread/needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "External detailed translation, registry/original-text and correction comparisons were not performed in this run.", "uncertainty": "External detailed translation, registry/original-text and correction comparisons were not performed in this run.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original text, language-specific revisions and dated correction events" }, { "item_id": "N32", "question_type": "Scope and evidence gaps for infection incidence versus symptom-days", "question": "What was the original scope of adverse-event collection and related serious safety signals?", "needed": "Collection/definitions, all events, severity and relatedness", "role": "Supplementary", "role_reason": "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_exception": "Do not turn no reported related serious signal into zero adverse effects of every kind or guaranteed safety.", "criterion": "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.", "basis": "M19 §19.1.2–19.2.4; Detailed distinctions are designed by CHAMGAP", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Research specifying harm collection separately from efficacy", "current_reports": [ "R01" ], "existence": "A preserved symptom-day trial summary exists; direct confirmed-infection and external details remain unread/needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "Some original summary information was linked for production; clinical verification/review is incomplete. Harm collection, all/serious events, relatedness and discontinuation tables are unverified.", "missingness": "Harm collection, all/serious events, relatedness and discontinuation tables are unverified.", "uncertainty": "Harm collection, all/serious events, relatedness and discontinuation tables are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Harm plans, all-event/discontinuation and relatedness tables" }, { "item_id": "N33", "question_type": "Scope and evidence gaps for infection incidence versus symptom-days", "question": "Are dairy allergy and lactose discomfort actual trial events?", "needed": "Original cautionary context versus the relevant population/events", "role": "Supplementary", "role_reason": "Needed to distinguish the original drink/population, people/days/events and unverified scope for: Are dairy allergy and lactose discomfort actual trial events?", "application_exception": "Do not create product-checking/avoidance, intake/treatment instructions or allergy/discomfort events absent from the original.", "criterion": "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.", "basis": "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", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Research specifying safety questions for vulnerable populations", "current_reports": [ "R01" ], "existence": "A preserved symptom-day trial summary exists; direct confirmed-infection and external details remain unread/needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "Some original summary information was linked for production; clinical verification/review is incomplete. Population selection, actual events/denominators, severity and relatedness are unverified.", "missingness": "Population selection, actual events/denominators, severity and relatedness are unverified.", "uncertainty": "Population selection, actual events/denominators, severity and relatedness are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Relevant populations/events and exposure/relatedness information" }, { "item_id": "N34", "question_type": "Scope and evidence gaps for infection incidence versus symptom-days", "question": "Were arm-specific harms, collection populations/denominators and effects verified?", "needed": "200/198/PPS 193 versus separate harm denominators/comparisons", "role": "Supplementary", "role_reason": "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_exception": "Do not automatically use PPS 193/97/96 as valid harm denominators or calculate zero events, incidence or CIs.", "criterion": "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.", "basis": "M19 §19.2.2–19.2.4, M03 §3.2.3; internal application; M19 §19.1.2–19.2.4; internal application", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Research distinguishing efficacy populations from harm-collection populations", "current_reports": [ "R01" ], "existence": "A preserved symptom-day trial summary exists; direct confirmed-infection and external details remain unread/needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "It is unverified whether randomized/completer/PPS populations match the harm-collection population. The summary lacks arm-specific harm events/denominators, comparisons and CIs.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Arm/period-specific collection, events/exposure denominators and comparative effects/CIs are unverified.", "uncertainty": "Arm/period-specific collection, events/exposure denominators and comparative effects/CIs are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Harm flow and arm-specific event/denominator tables" }, { "item_id": "N35", "question_type": "Scope and evidence gaps for infection incidence versus symptom-days", "question": "What were harm timing and post-study/delayed follow-up?", "needed": "12-week exposure, event/follow-up times and longer-term scope", "role": "Supplementary", "role_reason": "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_exception": "Do not turn 12-week symptom observation into completed long-term safety verification.", "criterion": "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.", "basis": "M19 §19.2 design-specific harm questions; temporal-relationship details are internally designed; M19 §19.1.2–19.2.4; internal application", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Research distinguishing timing and delayed harms", "current_reports": [ "R01" ], "existence": "A preserved symptom-day trial summary exists; direct confirmed-infection and external details remain unread/needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The original has a 12-week safety narrative but no separate event timing, period-specific observation or post-study/delayed-harm data.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Event timing, post-discontinuation/long-term observation and exposure changes are unverified.", "uncertainty": "Event timing, post-discontinuation/long-term observation and exposure changes are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Harm/exposure timing and follow-up information" }, { "item_id": "N36", "question_type": "Scope and evidence gaps for infection incidence versus symptom-days", "question": "How do shared yogurt, baseline/infection exposures and harm relatedness connect?", "needed": "LG2055/shared ingredients, concurrent drugs/illnesses and alternative causes", "role": "Supplementary", "role_reason": "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_exception": "Do not establish symptoms as outcomes of a specific pathogen or drink-related harm, or add cold-management/treatment instructions.", "criterion": "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.", "basis": "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", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "A plan distinguishing the exposure of interest from alternative causes", "current_reports": [ "R01" ], "existence": "A preserved symptom-day trial summary exists; direct confirmed-infection and external details remain unread/needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Medical history/drugs, exposures, actual events/relatedness and alternative causes are unverified.", "uncertainty": "Medical history/drugs, exposures, actual events/relatedness and alternative causes are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "History/concurrent exposures and event/cause-adjudication information" }, { "item_id": "N37", "question_type": "Scope and evidence gaps for infection incidence versus symptom-days", "question": "Are completion/exclusion and missing diaries distinguished from harm-related discontinuation?", "needed": "Original 198 completers/5 exclusions, PPS and harm/missingness reasons", "role": "Supplementary", "role_reason": "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_exception": "Do not convert the original 5 exclusions into people with adverse effects or calculate a new randomized/completer difference.", "criterion": "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.", "basis": "M19 §19.1.2–19.2.4, M04 §4.6.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "A plan separating missingness from harm-related discontinuation", "current_reports": [ "R01" ], "existence": "A preserved symptom-day trial summary exists; direct confirmed-infection and external details remain unread/needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "Original completion/exclusion counts are preserved, but harm/protocol/diary reasons and harm collection in omitted participants are not detailed.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Arm-specific exclusions/discontinuations/missingness, their harm relationships and collection/handling are unverified.", "uncertainty": "Arm-specific exclusions/discontinuations/missingness, their harm relationships and collection/handling are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Participant/diary flow, exclusions/harm-related discontinuations and missing data" }, { "item_id": "N38", "question_type": "Scope and evidence gaps for infection incidence versus symptom-days", "question": "How are independent harm data distinguished from observations in the same trial?", "needed": "Separate safety-report identities, exposures/populations and overlap", "role": "Supplementary", "role_reason": "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_exception": "No separate current slot does not establish the absence of all external harm reports.", "criterion": "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.", "basis": "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", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Independent safety research with clear populations/exposures", "current_reports": [ "R01" ], "existence": "A preserved symptom-day trial summary exists; direct confirmed-infection and external details remain unread/needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Independent harm-report identities, populations/exposures and overlap are unverified.", "uncertainty": "Independent harm-report identities, populations/exposures and overlap are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Separate harm/surveillance and event information" }, { "item_id": "N39", "question_type": "Scope and evidence gaps for infection incidence versus symptom-days", "question": "What is known about vulnerable populations, other illnesses/products and repeated/long-term safety?", "needed": "Healthy adults versus allergy/illness and long-term scope", "role": "Supplementary", "role_reason": "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_exception": "Do not propose implementation instructions for probiotic/product intake, cold management/prevention or treatment substitution.", "criterion": "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.", "basis": "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", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Research separating population and long-term safety questions", "current_reports": [ "R01" ], "existence": "A preserved symptom-day trial summary exists; direct confirmed-infection and external details remain unread/needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "A 12-week drink study in healthy adults cannot establish safety for other illnesses/ages, immune states, products or repeated/long-term exposures.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Vulnerable populations/concurrent medication, direct events and long-term/repeated-exposure data are unverified.", "uncertainty": "Vulnerable populations/concurrent medication, direct events and long-term/repeated-exposure data are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct harm data by population and exposure duration" }, { "item_id": "N40", "question_type": "Scope and evidence gaps for infection incidence versus symptom-days", "question": "Are the causal scopes of symptom-day benefit, infection gaps and the original good safety status distinguished?", "needed": "Different benefits/events, original safety and harm causality", "role": "Supplementary", "role_reason": "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_exception": "Do not newly classify unmeasured infection as zero effect, established harm or guaranteed safety.", "criterion": "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.", "basis": "Chamgap internal interpretation boundaries, informed by M19 principles without running an official causality tool; M03 §3.2.4; Internally defined extrapolation boundaries", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "A plan separating different outcomes and estimands", "current_reports": [ "R01" ], "existence": "A preserved symptom-day trial summary exists; direct confirmed-infection and external details remain unread/needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Direct confirmed-infection/comparative-harm data, causality and long-term precision are unverified.", "uncertainty": "Direct confirmed-infection/comparative-harm data, causality and long-term precision are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct infection and separate harm/follow-up data" }, { "item_id": "N41", "question_type": "Scope and evidence gaps for infection incidence versus symptom-days", "question": "How are follow-up materials, historical candidates/versions and incomplete prior content review connected?", "needed": "Review summary/criteria, original values/units, new materials and user decisions", "role": "Supplementary", "role_reason": "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_exception": "Do not invent current model/clinical review or completed publication from historical cross-checks or completed production.", "criterion": "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.", "basis": "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", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Research addressing direct gaps in confirmed-infection incidence", "current_reports": [ "R01" ], "existence": "A preserved symptom-day trial summary exists; direct confirmed-infection and external details remain unread/needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "No follow-up original materials, actual reading, changes or content-review/independence decisions yet exist.", "uncertainty": "No follow-up original materials, actual reading, changes or content-review/independence decisions yet exist.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional original materials, before/after values, versions and user-decision records" } ], "reports": [ { "report_id": "R01", "title": "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.", "url": "https://pubmed.ncbi.nlm.nih.gov/36570128/", "report_type": "Kobatake 2022 LG2055 yogurt questionnaire symptom-day contextual report; not a direct confirmed-infection trial", "existence": "Citation and preserved symptom-day summary exist; direct confirmed-infection and external details are unverified/unread", "acquired_read": "Summary read; external materials unread, access not attempted", "study_family": "SF01", "independent_replication": "The same people, arms, observation days, symptoms, times and sibling sheets are not added as new independent trials/participants.", "observed_result": "Runny nose 29.3% versus 34.3%, absolute difference −5.0 percentage points, P<0.001; 95% CI not reported", "result_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.", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Local preserved summary", "access_status": "Summary read", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only acquisition/reading of the complete parent summary is established, not original confirmed-infection research, paper or registry acquisition." }, { "material_type": "Abstract", "public_status": "External materials unread/needed", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Only the original citation link is connected. External access, content verification and link testing were not attempted." }, { "material_type": "Full paper", "public_status": "External materials unread/needed", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "The original bibliography supplies no DOI/PMCID. No original full text or external content was newly acquired/read." }, { "material_type": "Registration material", "public_status": "External materials unread/needed", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original UMIN000045901 and historical public/planned-start narrative are preserved. It is not NCT. External versions/content remain unread." }, { "material_type": "Protocol", "public_status": "External materials unread/needed", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original plans for identical yogurt/exposure, questionnaire/infection definitions, primary/secondary outcomes and harms are needed. Public availability/existence is unverified." }, { "material_type": "Statistical analysis plan", "public_status": "External materials unread/needed", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original plans for PPS/randomization, people/observation days, repetition/missingness, symptoms/composites and multiplicity are needed." }, { "material_type": "Outcome tables and questionnaire-day/infection/denominator/harm data", "public_status": "External materials unread/needed", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Symptom-day records/denominators, arm-specific PPS/flow and detailed harms are needed. Confirmed infection was originally unmeasured; separate direct data are needed." }, { "material_type": "Funding/conflict-of-interest disclosures", "public_status": "External materials unread/needed", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original disclosures on company development/employees, KSO contracting and support roles remain unread." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/36570128/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." } ], "status_dictionary": { "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." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "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." }, "history": [ { "date": "2026-10-14", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The reader view and materials were prepared from the existing 41 items. No new clinical search, verification-status changes or scoring were performed." } ], "language": "en", "translation_date": "2026-10-14" }