# DDMP lactic-acid-bacteria beverage × Original null finding for stratum-corneum moisture at 12 weeks

Verdict 2979 · Evidence Check

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

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

## Assessment scope

- Population: Healthy Japanese adults with dry skin; original 220 randomized/PPS 213 analyzed
- Ingredient, formulation and route: A 65 mL lactic-acid-bacteria beverage containing 2.2 mg DDMP
- Dose: Original 2.2 mg DDMP/65 mL beverage exposure is preserved; frequency/total intake are unverified. No intake/conversion instructions.
- Comparator: The identical lactic-acid-bacteria beverage with only DDMP removed
- Measured outcome: Final stratum-corneum moisture at 12 weeks (a.u.), distinguished from baseline change; site/environment/unit details are unverified
- Duration: 12 weeks, distinguished from intermediate weeks 4/8 and post-study/long-term effects
- Questions outside this scope: Replacing 12-week efficacy with positive intermediate week 4/8 or whole-time-model findings; Extending the DDMP identical-beverage contrast to all lactic-acid bacteria, other products or skin-disease effects; Converting final/change values, a.u. or ± into new effects, CIs or percentages; Adding people, arms, sites, visits, siblings or the same citation as independent trials/participants; Instructions for probiotic/product intake, skin/moisturizing management or treatment substitution

## Checklist items

### N01 · How is the selected 12-week question distinguished from intermediate-time sibling findings?

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

- Current findings: The selected original question is increased stratum-corneum moisture at 12 weeks. Its subclaim record is linked, while changes at weeks 4 and 8 remain original context. No new question, split or trial is created.
- Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Clinical independence was not newly certified.
- Reason for missing information: Clinical independence was not newly certified.
- Required materials and conditions: 12-week question/verdict connection and parent/intermediate scope
- Materials to obtain first: Original question/time, measurement/comparison and scope-change records
- Further research: A plan distinguishing final 12-week and intermediate estimands
- Conditions for verification: Separate original information about 12-week question/verdict connection and parent/intermediate scope from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
- Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: How is the selected 12-week question distinguished from intermediate-time sibling findings?
- Application exceptions: Do not fill the selected 12-week claim or grade with positive intermediate findings.
- Remaining uncertainty: Clinical independence was not newly certified.
- Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/outcome links are an internal application
- Related sources: R01

### N02 · What are the subclaim D grade/note and absent values?

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

- Current findings: The selected D grade and note, 29.7 versus 29.7 a.u., P=0.985, are preserved. Subclaim score/status/axes are absent; parent D28 and axes are separate historical context.
- Why unverified: Some original summary information is linked for production; this does not establish clinical verification/completed content review. Subclaim score/status/axes are absent in the original.
- Reason for missing information: Subclaim score/status/axes are absent in the original.
- Required materials and conditions: Subclaim grade/note, absent score/status/axes and parent history
- Materials to obtain first: Subclaim original and explicit change events
- Further research: Separate original-grade preservation from additional evidence/corrections
- Conditions for verification: Separate original information about Subclaim grade/note, absent score/status/axes and parent history from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
- Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What are the subclaim D grade/note and absent values?
- Application exceptions: Do not transfer parent 28 points or its original C0 axis into subclaim values or current review approval.
- Remaining uncertainty: Subclaim score/status/axes are absent in the original.
- Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design
- Related sources: R01

### N03 · Who was studied, and how are dry skin and disease distinguished?

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

- Current findings: The original records 220 healthy Japanese adults with dry skin. This is not direct treatment/moisturizing efficacy in skin-disease patients or all ages/regions.
- Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Age/sex, dry-skin criteria, baseline severity, eligibility/exclusions and illnesses/drugs are unverified.
- Reason for missing information: Age/sex, dry-skin criteria, baseline severity, eligibility/exclusions and illnesses/drugs are unverified.
- Required materials and conditions: Healthy Japanese adults with dry skin, eligibility and baseline scope
- Materials to obtain first: Eligibility criteria and baseline/diagnostic tables
- Further research: Research specifying the population and definition of dry skin
- Conditions for verification: Separate original information about Healthy Japanese adults with dry skin, eligibility and baseline scope from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
- Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: Who was studied, and how are dry skin and disease distinguished?
- Application exceptions: Do not extend measurements in healthy adults into skin-disease treatment or effects in every population.
- Remaining uncertainty: Age/sex, dry-skin criteria, baseline severity, eligibility/exclusions and illnesses/drugs are unverified.
- Referenced methods: M03 §3.2.1; detailed population conditions are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application
- Related sources: R01

### N04 · What is the studied identity of DDMP and the beverage?

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

- Current findings: The original intervention is a 65 mL lactic-acid-bacteria beverage containing 2.2 mg DDMP. The long chemical name remains in the original citation; DDMP is not replaced by a specific strain/organism count or all probiotics.
- Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Strains/counts, composition, manufacture, stability/assays and product specifications are unverified.
- Reason for missing information: Strains/counts, composition, manufacture, stability/assays and product specifications are unverified.
- Required materials and conditions: 2.2 mg DDMP, 65 mL beverage and chemical/product specifications
- Materials to obtain first: Beverage/ingredient specifications and analysis of the actual test product
- Further research: Research specifying the precise DDMP/beverage scope
- Conditions for verification: Separate original information about 2.2 mg DDMP, 65 mL beverage and chemical/product specifications from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
- Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What is the studied identity of DDMP and the beverage?
- Application exceptions: Do not newly add mechanisms, strains/counts, product names or dose conversions without original information.
- Remaining uncertainty: Strains/counts, composition, manufacture, stability/assays and product specifications are unverified.
- Referenced methods: M03 §§3.2.2–3.2.3; reverse-direction labels and assessment adaptation are Chamgap-designed; M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed
- Related sources: R01

### N05 · What comparison does the control beverage answer?

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

- Current findings: The original control is the same lactic-acid-bacteria beverage with only DDMP removed. It is not a comparison with no intake, another product or no lactic-acid bacteria.
- Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Equivalence specifications, sensory/compositional details and actual shared exposure/adherence are unverified.
- Reason for missing information: Equivalence specifications, sensory/compositional details and actual shared exposure/adherence are unverified.
- Required materials and conditions: Identical lactic-acid-bacteria beverage with only DDMP removed, differences/shared exposure
- Materials to obtain first: Test/control composition, quality and blinding information
- Further research: Research specifying the DDMP contrast on an identical-beverage background
- Conditions for verification: Separate original information about Identical lactic-acid-bacteria beverage with only DDMP removed, differences/shared exposure from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
- Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What comparison does the control beverage answer?
- Application exceptions: Do not extend the result into no benefit from all lactic-acid-bacteria beverages or the isolated effect of a particular strain.
- Remaining uncertainty: Equivalence specifications, sensory/compositional details and actual shared exposure/adherence are unverified.
- Referenced methods: M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application
- Related sources: R01

### N06 · What were original exposure, intake frequency and adherence?

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

- Current findings: The original gives a 65 mL beverage containing 2.2 mg and a 12-week duration. Intake frequency, daily total, timing and actual adherence quantities are not separately supplied in this summary.
- Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Frequency/timing, actual adherence, missing exposure and protocol deviations are unverified.
- Reason for missing information: Frequency/timing, actual adherence, missing exposure and protocol deviations are unverified.
- Required materials and conditions: Original 2.2 mg/65 mL, frequency and actual exposure
- Materials to obtain first: Study exposure schedule and adherence/provision records
- Further research: A plan separating intended provision from actual exposure
- Conditions for verification: Separate original information about Original 2.2 mg/65 mL, frequency and actual exposure from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
- Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What were original exposure, intake frequency and adherence?
- Application exceptions: Do not create or convert daily intake, probiotic/product instructions or management methods.
- Remaining uncertainty: Frequency/timing, actual adherence, missing exposure and protocol deviations are unverified.
- Referenced methods: M03 §3.2.2–3.2.3; Reverse-direction labeling and test adaptations are internally designed; M08 §8.2.2, M15 §15.3.1; Internal application; M03 §3.2.1–3.2.4; Dose, persistence and effect-modification details are internally designed
- Related sources: R01

### N07 · How are the 12-week endpoint, visits and persistence distinguished?

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

- Current findings: The original records 12-week follow-up, the final primary stratum-corneum moisture endpoint and intermediate weeks 4 and 8. Persistence after study completion and longer-use results are not supplied.
- Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Exact visit windows, post-completion/discontinuation follow-up and direct long-term results are unverified.
- Reason for missing information: Exact visit windows, post-completion/discontinuation follow-up and direct long-term results are unverified.
- Required materials and conditions: Final week 12, week 4/8 visits and post-discontinuation outcomes
- Materials to obtain first: Visit/exposure schedules and follow-up results
- Further research: Research separating final, intermediate and post-study questions
- Conditions for verification: Separate original information about Final week 12, week 4/8 visits and post-discontinuation outcomes from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
- Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: How are the 12-week endpoint, visits and persistence distinguished?
- Application exceptions: Do not establish sustained moisturizing benefit from positive intermediate findings or 12-week follow-up.
- Remaining uncertainty: Exact visit windows, post-completion/discontinuation follow-up and direct long-term results are unverified.
- Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed
- Related sources: R01

### N08 · What were measurement sites, methods/environment and moisture units?

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

- Current findings: The original final 12-week unit is a.u. (arbitrary units). Measurement sites, equipment, temperature/humidity, acclimation, repetitions and formulas are absent from the summary.
- Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Sites, equipment/environment, standardization, a.u. derivation and measurement error are unverified.
- Reason for missing information: Sites, equipment/environment, standardization, a.u. derivation and measurement error are unverified.
- Required materials and conditions: Skin measurement sites, equipment/environment and a.u. definition
- Materials to obtain first: Measurement methods, environment/sites and original test tables
- Further research: Research fixing site/environment and measurement definitions
- Conditions for verification: Separate original information about Skin measurement sites, equipment/environment and a.u. definition from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
- Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What were measurement sites, methods/environment and moisture units?
- Application exceptions: Do not turn a.u. into water-content percentages, site-specific effects or moisturizer/skin-care instructions.
- Remaining uncertainty: Sites, equipment/environment, standardization, a.u. derivation and measurement error are unverified.
- Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M03 §3.2.4; Internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are internally designed
- Related sources: R01

### N09 · What original comparison describes final absolute moisture at 12 weeks?

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

- Current findings: Original final 12-week values are 29.7±7.67 for the test beverage versus 29.7±6.19 a.u. for control, P=0.985. The original null narrative is preserved; no new difference, effect or CI is calculated.
- Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. The meaning of ±, arm-specific denominators, models/adjustments and site-specific/repeated data are unverified.
- Reason for missing information: The meaning of ±, arm-specific denominators, models/adjustments and site-specific/repeated data are unverified.
- Required materials and conditions: 29.7±7.67 versus 29.7±6.19 a.u. by condition, P=0.985
- Materials to obtain first: Final-value, model/denominator and measurement result tables
- Further research: Research specifying the final-visit between-arm estimand
- Conditions for verification: Separate original information about 29.7±7.67 versus 29.7±6.19 a.u. by condition, P=0.985 from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
- Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What original comparison describes final absolute moisture at 12 weeks?
- Application exceptions: Do not newly certify exactly zero effect, equivalence or no response in every person from equal displayed means.
- Remaining uncertainty: The meaning of ±, arm-specific denominators, models/adjustments and site-specific/repeated data are unverified.
- Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application
- Related sources: R01

### N10 · How does change from baseline at 12 weeks differ from final values?

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

- Current findings: Original 12-week change from baseline is +8.05±6.85 versus +7.92±5.97, P=0.877. This remains a different result representation from final 29.7 a.u.; positive within-arm change does not mean between-arm benefit.
- Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Separate change-unit specification, baseline values, ± definition, denominators/CIs and models are unverified.
- Reason for missing information: Separate change-unit specification, baseline values, ± definition, denominators/CIs and models are unverified.
- Required materials and conditions: +8.05±6.85 versus +7.92±5.97, P=0.877
- Materials to obtain first: Baseline/change and denominator/model result tables
- Further research: A plan separating final values from changes and within-arm from between-arm estimands
- Conditions for verification: Separate original information about +8.05±6.85 versus +7.92±5.97, P=0.877 from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
- Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: How does change from baseline at 12 weeks differ from final values?
- Application exceptions: Do not calculate new net effects, baseline values or percentages from the two changes.
- Remaining uncertainty: Separate change-unit specification, baseline values, ± definition, denominators/CIs and models are unverified.
- Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application
- Related sources: R01

### N11 · Are the original no-95%-CI narrative and uncertainty distinguished?

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

- Current findings: The original states that no 95% CI was reported and a meaningful benefit cannot be excluded. No external paper was newly read in this run to verify that reporting statement.
- Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. The estimand's CI, variance definition/covariance and importance/equivalence criteria are unverified.
- Reason for missing information: The estimand's CI, variance definition/covariance and importance/equivalence criteria are unverified.
- Required materials and conditions: Original no-CI narrative, effect intervals/importance and meaning of ±
- Materials to obtain first: Original analysis results and precision/importance plans
- Further research: Research prespecifying effects, intervals and importance
- Conditions for verification: Separate original information about Original no-CI narrative, effect intervals/importance and meaning of ± from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
- Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: Are the original no-95%-CI narrative and uncertainty distinguished?
- Application exceptions: Do not arbitrarily interpret ± as CI/SD or reconstruct CIs from the original numbers.
- Remaining uncertainty: The estimand's CI, variance definition/covariance and importance/equivalence criteria are unverified.
- Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are internally designed; M15 §15.3.1–15.3.3; Internal application; M04 §4.5, §4.6.3; Current conversion limits follow the review scope and internal design
- Related sources: R01

### N12 · Which time points do positive week 4/8 findings describe?

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

- Current findings: Original week 4 changes +4.28 versus −2.09 (P<0.001) and week 8 +8.47 versus +5.17 (P=0.002) are preserved. The sibling is C with a positive-intermediate/disappearing-final note; it does not replace the selected 12-week D result.
- Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Intermediate variance/CIs, denominators, units/hierarchy and multiplicity are unverified.
- Reason for missing information: Intermediate variance/CIs, denominators, units/hierarchy and multiplicity are unverified.
- Required materials and conditions: Intermediate changes/P values, sibling original grade and final-visit boundary
- Materials to obtain first: Intermediate/final results and protocol/SAP
- Further research: Research fixing visit-specific estimands and hierarchy
- Conditions for verification: Separate original information about Intermediate changes/P values, sibling original grade and final-visit boundary from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
- Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: Which time points do positive week 4/8 findings describe?
- Application exceptions: Do not copy week 4/8 numbers into week 12 or new independent trials/replications, or calculate new time-specific differences.
- Remaining uncertainty: Intermediate variance/CIs, denominators, units/hierarchy and multiplicity are unverified.
- Referenced methods: M04 §4.6.3, M15 §15.3.1–15.3.3; Status separation is internally designed; M08 Table 8.2.a, M04 §4.6.3; Internal application; M03 §3.2.1–3.2.4; Dose, persistence and effect-modification details are internally designed
- Related sources: R01

### N13 · What does a positive whole-time mixed model mean?

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

- Current findings: The original counterview records that whole-time mixed-model P<0.001 describes differing trajectories, not a 12-week effect. It does not replace final P=.985/.877.
- Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Models, interactions/effect definitions, covariates, results/denominators and multiplicity are unverified.
- Reason for missing information: Models, interactions/effect definitions, covariates, results/denominators and multiplicity are unverified.
- Required materials and conditions: Whole-time P<0.001 versus final 12-week and change results
- Materials to obtain first: Time-model/SAP and visit-specific analyses
- Further research: Research separating longitudinal estimands from final contrasts
- Conditions for verification: Separate original information about Whole-time P<0.001 versus final 12-week and change results from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
- Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What does a positive whole-time mixed model mean?
- Application exceptions: Do not newly grade whole-time significance as 12-week primary-efficacy success or persistent benefit.
- Remaining uncertainty: Models, interactions/effect definitions, covariates, results/denominators and multiplicity are unverified.
- Referenced methods: M08 §8.2.2, M15 §15.3.1; Internal application; M08 Table 8.2.a, M04 §4.6.3; Internal application; M04 §4.6.3, M15 §15.3.1–15.3.3; Status separation is internally designed
- Related sources: R01

### N14 · What is known about prespecified final-primary versus intermediate/secondary hierarchy?

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

- Current findings: Original bilingual text/evidence records week 12 as the prespecified final primary endpoint. Exact prespecified secondary/exploratory hierarchy and success/multiplicity rules for intermediate visits are absent.
- Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Actual external planning versions, hierarchy/timing and testing rules remain unread.
- Reason for missing information: Actual external planning versions, hierarchy/timing and testing rules remain unread.
- Required materials and conditions: Original final-primary narrative, registry/SAP and intermediate hierarchy
- Materials to obtain first: Registry, protocol/SAP and outcome lists
- Further research: A plan separating final/intermediate and primary/secondary/exploratory outcomes
- Conditions for verification: Separate original information about Original final-primary narrative, registry/SAP and intermediate hierarchy from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
- Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What is known about prespecified final-primary versus intermediate/secondary hierarchy?
- Application exceptions: Preserve the original prespecification narrative without inventing current external registry-content certification.
- Remaining uncertainty: Actual external planning versions, hierarchy/timing and testing rules remain unread.
- Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific result adaptation is our own design; M08 Table 8.2.a, M04 §4.6.3; own application
- Related sources: R01

### N15 · What registration and bibliographic identifiers are supplied or absent?

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

- Current findings: The original registration record contains UMIN000052867 and the citation supplies PMID40151405. It is linked as a UMIN ID, not NCT. DOI/PMCID are absent from the citation.
- Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. DOI/PMCID, registry versions/content and protocol/SAP are currently unverified.
- Reason for missing information: DOI/PMCID, registry versions/content and protocol/SAP are currently unverified.
- Required materials and conditions: UMIN000052867, PMID40151405 and DOI/PMCID scope
- Materials to obtain first: Original bibliography/registry and protocol/SAP
- Further research: Link identifiers, prespecified plans and published results
- Conditions for verification: Separate original information about UMIN000052867, PMID40151405 and DOI/PMCID scope from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
- Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What registration and bibliographic identifiers are supplied or absent?
- Application exceptions: Do not turn absent identifiers into actual non-registration, absent full text or failed access, or guess a DOI.
- Remaining uncertainty: DOI/PMCID, registry versions/content and protocol/SAP are currently unverified.
- Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M08 Table 8.2.a, M04 §4.6.3; internal application
- Related sources: R01

### N16 · Are all 220 randomized participants distinguished from 213 protocol-compliant analyses?

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

- Current findings: Original 220 randomized and 213 protocol-compliant participants analyzed are preserved. Arm-specific randomized/analysis and valid outcome/visit denominators are not separately supplied.
- Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Arm/visit-specific analysis counts, PPS selection rules and exclusion reasons are unverified.
- Reason for missing information: Arm/visit-specific analysis counts, PPS selection rules and exclusion reasons are unverified.
- Required materials and conditions: Randomized versus PPS populations and arm/outcome-specific denominators
- Materials to obtain first: Participant flow, arm/visit denominators and PPS criteria
- Further research: Research prespecifying randomized versus analysis populations
- Conditions for verification: Separate original information about Randomized versus PPS populations and arm/outcome-specific denominators from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
- Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: Are all 220 randomized participants distinguished from 213 protocol-compliant analyses?
- Application exceptions: Do not newly calculate 220−213, arm samples or attrition rates.
- Remaining uncertainty: Arm/visit-specific analysis counts, PPS selection rules and exclusion reasons are unverified.
- Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application
- Related sources: R01

### N17 · What were actual attrition, protocol-deviation and missing-measurement reasons?

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

- Current findings: PPS 213 alone does not establish whether exclusions reflect lost follow-up, exposure violations, missing measurements or other reasons. ITT, imputation and sensitivity analyses are absent.
- Why unverified: Needed direct information was not verified within the current summary and unread-external-material scope. Arm-specific flow/reasons, missing-data handling, all-randomized analyses and sensitivities are unverified.
- Reason for missing information: Arm-specific flow/reasons, missing-data handling, all-randomized analyses and sensitivities are unverified.
- Required materials and conditions: Not analyzed/missing, adherence deviations, discontinuation and handling
- Materials to obtain first: Participant flow, deviation/missingness records and SAP
- Further research: Research separating missingness/deviations from estimands
- Conditions for verification: Separate original information about Not analyzed/missing, adherence deviations, discontinuation and handling from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
- Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What were actual attrition, protocol-deviation and missing-measurement reasons?
- Application exceptions: Do not turn every PPS exclusion into attrition/adverse effects or create new numbers or flaw grades.
- Remaining uncertainty: Arm-specific flow/reasons, missing-data handling, all-randomized analyses and sensitivities are unverified.
- Referenced methods: M08 §8.2.2, M15 §15.3.1; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application; M19 §19.1.2–19.2.4, M04 §4.6.3; internal application
- Related sources: R01

### N18 · How do skin sites, repeated measurements and arms/visits differ from people?

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

- Current findings: Original samples are 220/213 people; measurement sites/repeated aggregation are unverified. The same people, arms, sites and weeks 4/8/12 are not added as new independent trials/participants.
- Why unverified: Needed direct information was not verified within the current summary and unread-external-material scope. Site-specific observations, repetitions/aggregation, correlation handling and denominators are unverified.
- Reason for missing information: Site-specific observations, repetitions/aggregation, correlation handling and denominators are unverified.
- Required materials and conditions: Analysis units for people, multiple sites/measurements and visits
- Materials to obtain first: Site/visit data and analysis-unit/SAP information
- Further research: A plan separating people from repeated sites/time points
- Conditions for verification: Separate original information about Analysis units for people, multiple sites/measurements and visits from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
- Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: How do skin sites, repeated measurements and arms/visits differ from people?
- Application exceptions: Do not invent skin-site/night data or newly add visit-specific samples.
- Remaining uncertainty: Site-specific observations, repetitions/aggregation, correlation handling and denominators are unverified.
- Referenced methods: Distinguishing studies from reports in M04 §4.6.1–4.6.2; Cohort/outcome linkage is an internal application; M08 Table 8.2.a, M03 §3.2.4; Internal application; M08 §8.2.2, M15 §15.3.1; Internal application
- Related sources: R01

### N19 · What were baseline conditions, environment/season and concurrent moisturizing exposures?

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

- Current findings: The current summary has no detailed control or arm differences for baseline moisture, environment/season, skin care/diet or concurrent treatment.
- Why unverified: Needed direct information was not verified within the current summary and unread-external-material scope. Baseline testing, environment/season, shared management/drugs and exposure records are unverified.
- Reason for missing information: Baseline testing, environment/season, shared management/drugs and exposure records are unverified.
- Required materials and conditions: Arm-specific baseline moisture, environment/lifestyle and concurrent skin care
- Materials to obtain first: Baseline/measurement environment, concurrent exposures and protocol
- Further research: Research specifying measurement environment and shared exposures
- Conditions for verification: Separate original information about Arm-specific baseline moisture, environment/lifestyle and concurrent skin care from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
- Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What were baseline conditions, environment/season and concurrent moisturizing exposures?
- Application exceptions: Do not newly add management methods, moisturizing products/treatments as actual study elements or implementation instructions.
- Remaining uncertainty: Baseline testing, environment/season, shared management/drugs and exposure records are unverified.
- Referenced methods: M03 §3.2.3, M08 §8.2.2–8.2.3; Internal application; M08 Table 8.2.a, M03 §3.2.4; Internal application; Design considerations in M19 §19.2.2–19.2.4; Detailed confounding records are internally designed
- Related sources: R01

### N20 · Were randomization, allocation concealment and baseline balance verified?

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

- Current findings: The original design is a double-blind randomized identical-beverage placebo-controlled parallel trial. Allocation procedures, concealment and baseline balance are not detailed in the summary.
- Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Sequence generation, concealment, allocation responsibility and arm-specific baseline data are unverified.
- Reason for missing information: Sequence generation, concealment, allocation responsibility and arm-specific baseline data are unverified.
- Required materials and conditions: Parallel randomization, sequence/concealment and baseline tables
- Materials to obtain first: Allocation procedures, baseline tables and protocol
- Further research: An allocation plan for the identical-beverage comparison
- Conditions for verification: Separate original information about Parallel randomization, sequence/concealment and baseline tables from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
- Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: Were randomization, allocation concealment and baseline balance verified?
- Application exceptions: Do not certify adequate allocation or no bias from the RCT label or original B1 axis alone.
- Remaining uncertainty: Sequence generation, concealment, allocation responsibility and arm-specific baseline data are unverified.
- Referenced methods: M08 §8.1–8.2.3; own application
- Related sources: R01

### N21 · What was the actual scope of double blinding, beverage equivalence and measurement procedures?

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

- Current findings: The original records double blinding and identical beverages. Who was blinded and how, equivalence/condition awareness and moisture-measurement standardization are absent.
- Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Blinded parties/procedures, sensory equivalence, condition awareness and measurement/analysis procedures are unverified.
- Reason for missing information: Blinded parties/procedures, sensory equivalence, condition awareness and measurement/analysis procedures are unverified.
- Required materials and conditions: Blinding of participants/measurers/analysts, equivalence and condition awareness
- Materials to obtain first: Blinding/equivalence and measurement-standardization information
- Further research: Research specifying measurement and condition awareness
- Conditions for verification: Separate original information about Blinding of participants/measurers/analysts, equivalence and condition awareness from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
- Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What was the actual scope of double blinding, beverage equivalence and measurement procedures?
- Application exceptions: Do not inherit the original double-blind design as current successful-blinding review or independence certification.
- Remaining uncertainty: Blinded parties/procedures, sensory equivalence, condition awareness and measurement/analysis procedures are unverified.
- Referenced methods: M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application
- Related sources: R01

### N22 · What are PPS, absolute/change and within-/between-arm estimands?

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

- Current findings: Primary PPS 213 and original final 12-week/change-from-baseline contrasts are distinguished. Baseline/covariate adjustment, estimands and models are not detailed.
- Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Analysis populations/models, adjustments, absolute/change values and all-randomized contrasts are unverified.
- Reason for missing information: Analysis populations/models, adjustments, absolute/change values and all-randomized contrasts are unverified.
- Required materials and conditions: Assignment/adherent-participant effects and original final/change analyses
- Materials to obtain first: SAP and results/denominators for each estimand
- Further research: Research specifying assignment/adherent and final/change estimands
- Conditions for verification: Separate original information about Assignment/adherent-participant effects and original final/change analyses from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
- Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What are PPS, absolute/change and within-/between-arm estimands?
- Application exceptions: Do not copy PPS results as all-randomized effects or turn within-arm changes into between-arm efficacy.
- Remaining uncertainty: Analysis populations/models, adjustments, absolute/change values and all-randomized contrasts are unverified.
- Referenced methods: M08 §8.2.2 and M15 §15.3.1: in-house application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4: design-specific adaptation is in-house.
- Related sources: R01

### N23 · What original information concerns manufacturers, contractors and provision/support?

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

- Current findings: The original states Nissin York supplied test/placebo beverages; T.S., M.T. and S.S. worked at its development institute, while M.M. worked at contract organization M&I Science. The original no-separate-public-funding/medical-writing/publication-fee narrative is preserved.
- Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Current detailed original disclosures, support and design/analysis/data-access roles remain unread.
- Reason for missing information: Current detailed original disclosures, support and design/analysis/data-access roles remain unread.
- Required materials and conditions: Nissin York provision, employee authors, M&I Science and support scope
- Materials to obtain first: Original support/provision, author relationships/roles and disclosures
- Further research: Specify support and decision/analysis roles
- Conditions for verification: Separate original information about Nissin York provision, employee authors, M&I Science and support scope from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
- Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What original information concerns manufacturers, contractors and provision/support?
- Application exceptions: Do not combine the contractor author with company employee authors or turn original support narratives into current content-review/independence judgments.
- Remaining uncertainty: Current detailed original disclosures, support and design/analysis/data-access roles remain unread.
- Referenced methods: Chamgap’s own independence/attribution conditions. The official methodological sections used in this pilot do not guarantee every detailed item; M08 §8.1–8.2.3; internal application
- Related sources: R01

### N24 · How are the same citation, trial, time points and siblings linked?

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

- Current findings: Current evidence/citation lists each contain one Sato2025 record, linked as one report. Both identical-beverage arms, weeks 4/8/12, skin sites and siblings share this context; they are not newly added independent trials/participants.
- Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Related report/trial relationships and unique trial/participant totals are unverified.
- Reason for missing information: Related report/trial relationships and unique trial/participant totals are unverified.
- Required materials and conditions: The same Sato2025 report and observation/participant relationships
- Materials to obtain first: Trial/related-report identities and observation units
- Further research: Records distinguishing reports from study families
- Conditions for verification: Separate original information about The same Sato2025 report and observation/participant relationships from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
- Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: How are the same citation, trial, time points and siblings linked?
- Application exceptions: One report is not certification of the total independent-trial count or final clinical-independence count.
- Remaining uncertainty: Related report/trial relationships and unique trial/participant totals are unverified.
- Referenced methods: Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application
- Related sources: R01

### N25 · What direct independent replications or other manufacturer/product data exist?

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

- Current findings: The original records one manufacturer-linked trial and historical R1/I0 axes. Other direct studies/products were not searched for or verified in this run.
- Why unverified: Needed direct information was not verified within the current summary and unread-external-material scope. Separate direct-report populations, beverages/endpoints, overlap and independence are unverified.
- Reason for missing information: Separate direct-report populations, beverages/endpoints, overlap and independence are unverified.
- Required materials and conditions: Separate independent reports for the same 12-week DDMP-beverage question
- Materials to obtain first: Direct confirmatory/replication reports and trial identities
- Further research: Separate research addressing the same question
- Conditions for verification: Separate original information about Separate independent reports for the same 12-week DDMP-beverage question from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
- Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What direct independent replications or other manufacturer/product data exist?
- Application exceptions: Do not extend the original single-trial narrative into a current absence of every study, or count sibling tables as independent replication.
- Remaining uncertainty: Separate direct-report populations, beverages/endpoints, overlap and independence are unverified.
- Referenced methods: Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application
- Related sources: R01

### N26 · What are extrapolation boundaries for other beverages/strains, populations and sites?

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

- Current findings: Original scope is a DDMP-containing identical-beverage comparison in healthy Japanese adults with dry skin. Direct values for other bacteria/beverages, products, skin diseases/populations/sites are not supplied.
- Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Direct effects/CIs and interactions by population, product or site are unverified.
- Reason for missing information: Direct effects/CIs and interactions by population, product or site are unverified.
- Required materials and conditions: Studied identity versus direct comparisons for other formulations/populations/sites
- Materials to obtain first: Direct formulation/population/measurement-site data
- Further research: Research specifying precise study identity and applicability
- Conditions for verification: Separate original information about Studied identity versus direct comparisons for other formulations/populations/sites from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
- Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What are extrapolation boundaries for other beverages/strains, populations and sites?
- Application exceptions: Do not newly declare no benefit from all lactic-acid bacteria or create product recommendations/intake/skin-care instructions.
- Remaining uncertainty: Direct effects/CIs and interactions by population, product or site are unverified.
- Referenced methods: M03 §3.2.1; Detailed population conditions are internally designed; M03 §3.2.2–3.2.3; Reverse-direction labeling and test adaptations are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; Internal application; M03 §3.2.1–3.2.4; Dose, persistence and effect-modification details are internally designed
- Related sources: R01

### N27 · Are intermediate differences, final disappearance and persistence distinguished?

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

- Current findings: The original states intermediate differences disappeared at week 12 and benefit did not persist. Post-week-12 persistence, repeated-use and recurrence data are absent.
- Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Direct post-discontinuation/longer-term effects, denominators and CIs are unverified.
- Reason for missing information: Direct post-discontinuation/longer-term effects, denominators and CIs are unverified.
- Required materials and conditions: Original week 4/8 positive findings, final week 12 null finding and longer term
- Materials to obtain first: Time-specific/post-study results and plans
- Further research: Research distinguishing timing/persistence questions
- Conditions for verification: Separate original information about Original week 4/8 positive findings, final week 12 null finding and longer term from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
- Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: Are intermediate differences, final disappearance and persistence distinguished?
- Application exceptions: Preserve the original conclusion without extending it into zero effect in every long-term situation or permanently no effect.
- Remaining uncertainty: Direct post-discontinuation/longer-term effects, denominators and CIs are unverified.
- Referenced methods: M03 §3.2.1–3.2.4; Dose, persistence and effect-modification details are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; Status separation is internally designed
- Related sources: R01

### N28 · What do stratum-corneum moisture versus symptom/clinical skin outcomes answer?

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

- Current findings: The original endpoint is stratum-corneum moisture. Separate direct treatment effects on symptoms, quality of life or clinical skin-disease outcomes are absent.
- Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Patient-important/disease outcome definitions, effects, denominators and durations are unverified.
- Reason for missing information: Patient-important/disease outcome definitions, effects, denominators and durations are unverified.
- Required materials and conditions: Measurement endpoints versus skin symptoms, quality of life and disease treatment
- Materials to obtain first: Direct symptom/clinical-outcome information
- Further research: A plan separating moisture testing from patient-important outcomes
- Conditions for verification: Separate original information about Measurement endpoints versus skin symptoms, quality of life and disease treatment from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
- Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What do stratum-corneum moisture versus symptom/clinical skin outcomes answer?
- Application exceptions: Do not turn null measurements into no benefit from every skin treatment, treatment substitution or moisturizing-management instructions.
- Remaining uncertainty: Patient-important/disease outcome definitions, effects, denominators and durations are unverified.
- Referenced methods: M03 §3.2.4; internally defined extension boundary; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed
- Related sources: R01

### N29 · What was actually read, externally unread and linked?

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

- Current findings: The complete preserved 2979 summary was read and saved for production. Original PubMed and UMIN identifiers connect sources; external content/link access, clicks and tests were not performed in that production.
- Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Current external original methods/results and registry/plans remain unverified.
- Reason for missing information: Current external original methods/results and registry/plans remain unverified.
- Required materials and conditions: Complete preserved summary, abstract/full text/plans and source connections
- Materials to obtain first: Acquired original materials and actual reading/addition events
- Further research: Records separating preserved summaries from newly acquired materials
- Conditions for verification: Separate original information about Complete preserved summary, abstract/full text/plans and source connections from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
- Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What was actually read, externally unread and linked?
- Application exceptions: Do not declare external acquisition/reading, successful access or failed access based on a URL/ID.
- Remaining uncertainty: Current external original methods/results and registry/plans remain unverified.
- Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design
- Related sources: R01

### N30 · What are original bilingual text, dates, axes/absences, corrections and history?

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

- Current findings: Bilingual text, the original date 2026-08-26, empty correction/deliberation records and parent D28 are preserved. B/S/R1/I0/E0/B1/C0 axes, three false flags and empty override reasons are historical. Original detailed-classification and primary-failure/secondary-positive fields are absent.
- Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. External detailed translation, original-text and correction comparisons were not performed in this run.
- Reason for missing information: External detailed translation, original-text and correction comparisons were not performed in this run.
- Required materials and conditions: Original languages/dates, parent axes/score and empty/absent values
- Materials to obtain first: Language-specific originals/revisions and dated correction events
- Further research: Separate original values/absences from new updates
- Conditions for verification: Separate original information about Original languages/dates, parent axes/score and empty/absent values from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
- Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What are original bilingual text, dates, axes/absences, corrections and history?
- Application exceptions: Do not inherit original flaw/size/duration scoring or cross-check wording as current review/rescoring, or invent absent fields.
- Remaining uncertainty: External detailed translation, original-text and correction comparisons were not performed in this run.
- Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed splitting rules are internally designed; M04 §4.5, §4.6.3; current material-conversion limits follow review scope and internal design; Chamgap’s own independence/attribution conditions. The official methodological sections used in this pilot do not guarantee every detailed item
- Related sources: R01

### N31 · What was the original scope of adverse-event collection and serious safety signals?

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

- Current findings: The original records no reported serious safety signal related to the test beverage during 12-week intake. Collection methods, all-event/severity and relatedness-adjudication tables are absent.
- Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Adverse-event definitions/collection, all events and relatedness adjudication are unverified.
- Reason for missing information: Adverse-event definitions/collection, all events and relatedness adjudication are unverified.
- Required materials and conditions: Collection methods/definitions, severity, relatedness and original narrative
- Materials to obtain first: Harm plans, event/discontinuation and relatedness tables
- Further research: Research specifying harm collection separately from efficacy
- Conditions for verification: Separate original information about Collection methods/definitions, severity, relatedness and original narrative from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
- Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What was the original scope of adverse-event collection and serious safety signals?
- Application exceptions: Do not turn no reported serious related signal into zero adverse events of all types or guaranteed absence of harm/safety.
- Remaining uncertainty: Adverse-event definitions/collection, all events and relatedness adjudication are unverified.
- Referenced methods: M19 §19.1.2–19.2.4; Detailed distinctions are designed by CHAMGAP
- Related sources: R01

### N32 · Are dairy-allergy/intolerance cautions actual events?

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

- Current findings: The original separately mentions dairy-ingredient allergy/intolerance. This is not a count or causal result showing allergy events occurred in this trial.
- Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Eligibility/relevant populations and actual events/denominators/severity are unverified.
- Reason for missing information: Eligibility/relevant populations and actual events/denominators/severity are unverified.
- Required materials and conditions: Original cautionary context and relevant populations/event data
- Materials to obtain first: Population/event and exposure/relatedness data
- Further research: Safety questions specifying vulnerable populations
- Conditions for verification: Separate original information about Original cautionary context and relevant populations/event data from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
- Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: Are dairy-allergy/intolerance cautions actual events?
- Application exceptions: Do not create new product-checking/avoidance, intake/treatment instructions or allergy counts absent from the original.
- Remaining uncertainty: Eligibility/relevant populations and actual events/denominators/severity are unverified.
- Referenced methods: M19 §19.1.2–19.2.4; Detailed distinctions are internally designed; M19 §19.1.2–19.2.4; Internal application; Chamgap internal interpretation boundaries, informed by M19 principles without running an official causality tool
- Related sources: R01

### N33 · Were arm-specific harms and event/exposure denominators verified?

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

- Current findings: It is unverified whether all 220/PPS 213 match the harm-collection population. Arm-specific events/denominators, effects and CIs are absent.
- Why unverified: Needed direct information was not verified within the current summary and unread-external-material scope. Arm/period-specific harm denominators, events and comparative effects/CIs are unverified.
- Reason for missing information: Arm/period-specific harm denominators, events and comparative effects/CIs are unverified.
- Required materials and conditions: All-randomized/PPS populations versus harm collection and arm comparisons
- Materials to obtain first: Harm flow and events/denominator tables by arm
- Further research: A plan separating efficacy from harm-collection populations
- Conditions for verification: Separate original information about All-randomized/PPS populations versus harm collection and arm comparisons from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
- Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: Were arm-specific harms and event/exposure denominators verified?
- Application exceptions: Do not automatically apply PPS 213 as a harm denominator or calculate zero events, incidence, differences or CIs.
- Remaining uncertainty: Arm/period-specific harm denominators, events and comparative effects/CIs are unverified.
- Referenced methods: M19 §19.2.2–19.2.4, M03 §3.2.3; internal application; M19 §19.1.2–19.2.4; internal application
- Related sources: R01

### N34 · What were harm timing and on-/post-exposure follow-up?

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

- Current findings: The original has a safety narrative for 12-week exposure but no separate event timing, period-specific observation or post-study/delayed-harm follow-up.
- Why unverified: Needed direct information was not verified within the current summary and unread-external-material scope. Event timing and on-exposure/post-discontinuation/long-term observation are unverified.
- Reason for missing information: Event timing and on-exposure/post-discontinuation/long-term observation are unverified.
- Required materials and conditions: 12-week scope, event timing and post-discontinuation/delayed observation
- Materials to obtain first: Harm/exposure timing and follow-up information
- Further research: Research prespecifying timing and delayed harms
- Conditions for verification: Separate original information about 12-week scope, event timing and post-discontinuation/delayed observation from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
- Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What were harm timing and on-/post-exposure follow-up?
- Application exceptions: Do not turn 12-week efficacy duration into completed long-term safety verification.
- Remaining uncertainty: Event timing and on-exposure/post-discontinuation/long-term observation are unverified.
- Referenced methods: M19 §19.2 design-specific harm questions; temporal-relationship details are internally designed; M19 §19.1.2–19.2.4; internal application
- Related sources: R01

### N35 · What alternative causes concern DDMP, shared beverage, illnesses or drugs?

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

- Current findings: The context compares presence/absence of DDMP in identical beverages. Actual information attributing harm to DDMP, the shared beverage or other factors is absent.
- Why unverified: Needed direct information was not verified within the current summary and unread-external-material scope. Medical history/drugs, actual exposures and event-specific alternative causes/relatedness are unverified.
- Reason for missing information: Medical history/drugs, actual exposures and event-specific alternative causes/relatedness are unverified.
- Required materials and conditions: Shared dairy/beverage, concurrent exposures and harm attribution
- Materials to obtain first: History/exposure and event/relatedness records
- Further research: A harm plan separating the exposure of interest from alternative causes
- Conditions for verification: Separate original information about Shared dairy/beverage, concurrent exposures and harm attribution from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
- Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What alternative causes concern DDMP, shared beverage, illnesses or drugs?
- Application exceptions: Do not turn shared-ingredient cautions into established DDMP harms or new treatment/prevention instructions.
- Remaining uncertainty: Medical history/drugs, actual exposures and event-specific alternative causes/relatedness are unverified.
- Referenced methods: M19 §19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap design; M03 §3.2.3, M08 §8.2.2–8.2.3; Chamgap adaptation
- Related sources: R01

### N36 · Were PPS exclusions, missingness and harm-related discontinuations verified?

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

- Current findings: PPS 213 alone does not establish whether analysis exclusions were harm-related. Event collection/handling in omitted participants is also absent.
- Why unverified: Needed direct information was not verified within the current summary and unread-external-material scope. Arm-specific exclusions/missingness/discontinuations, relatedness and collection/handling are unverified.
- Reason for missing information: Arm-specific exclusions/missingness/discontinuations, relatedness and collection/handling are unverified.
- Required materials and conditions: PPS populations, exclusion/discontinuation reasons and missing harm collection
- Materials to obtain first: Flow/exclusions, harm-related discontinuations and missing data
- Further research: A plan distinguishing missingness from harm-related discontinuation
- Conditions for verification: Separate original information about PPS populations, exclusion/discontinuation reasons and missing harm collection from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
- Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: Were PPS exclusions, missingness and harm-related discontinuations verified?
- Application exceptions: Do not calculate new differences/ratios from 220/213 or turn exclusions into people with adverse effects.
- Remaining uncertainty: Arm-specific exclusions/missingness/discontinuations, relatedness and collection/handling are unverified.
- Referenced methods: M19 §19.1.2–19.2.4, M04 §4.6.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application
- Related sources: R01

### N37 · How are independent harm reports distinguished from observations in the same trial?

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

- Current findings: The current listing is this beverage efficacy report. Separate original harm materials were not searched for/acquired in this run; the same report, arms, visits and siblings are not independent harm trials.
- Why unverified: Needed direct information was not verified within the current summary and unread-external-material scope. Independent harm-report identities, populations/exposures and overlap are unverified.
- Reason for missing information: Independent harm-report identities, populations/exposures and overlap are unverified.
- Required materials and conditions: Separate harm identities, exposures/populations and overlap
- Materials to obtain first: Separate harm/surveillance and event materials
- Further research: Independent harm research with clear exposures/populations
- Conditions for verification: Separate original information about Separate harm identities, exposures/populations and overlap from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
- Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: How are independent harm reports distinguished from observations in the same trial?
- Application exceptions: No separate current slot does not establish absence of every external harm report.
- Remaining uncertainty: Independent harm-report identities, populations/exposures and overlap are unverified.
- Referenced methods: M04 §§4.6.1–4.6.2; harm-material adaptation is Chamgap-designed; M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations
- Related sources: R01

### N38 · What is known about vulnerable populations, other illnesses/beverages and long-term safety?

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

- Current findings: 12-week data in healthy Japanese adults with dry skin do not establish safety for other beverages/populations, illnesses or longer repeated exposure.
- Why unverified: Needed direct information was not verified within the current summary and unread-external-material scope. Population-specific histories/drugs and direct long-term/repeated harms are unverified.
- Reason for missing information: Population-specific histories/drugs and direct long-term/repeated harms are unverified.
- Required materials and conditions: Original healthy adults versus allergy/illness and repeated/long-term scope
- Materials to obtain first: Direct harm data by vulnerable/disease population and exposure duration
- Further research: Research separating population and long-term safety questions
- Conditions for verification: Separate original information about Original healthy adults versus allergy/illness and repeated/long-term scope from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
- Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What is known about vulnerable populations, other illnesses/beverages and long-term safety?
- Application exceptions: Do not newly propose probiotic/product intake, skin-care or treatment-substitution methods.
- Remaining uncertainty: Population-specific histories/drugs and direct long-term/repeated harms are unverified.
- Referenced methods: M19 §19.1.2–19.2.4; Internal application; Design considerations in M19 §19.2.2–19.2.4; Detailed confounding records are internally designed
- Related sources: R01

### N39 · What are the causal scopes of final null, intermediate positive and good safety findings?

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

- Current findings: Original 12-week null findings, positive week 4/8 findings, no reported serious related safety signal and parent good safety status are preserved separately. Null efficacy does not establish harms or guarantee safety.
- Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Direct comparative/causal safety and long-term precision are unverified.
- Reason for missing information: Direct comparative/causal safety and long-term precision are unverified.
- Required materials and conditions: Separate efficacy/timing, original safety grade and comparative harms
- Materials to obtain first: Separate comparative-harm/follow-up data alongside efficacy
- Further research: Plan separating different outcomes/estimands
- Conditions for verification: Separate original information about Separate efficacy/timing, original safety grade and comparative harms from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
- Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What are the causal scopes of final null, intermediate positive and good safety findings?
- Application exceptions: Do not extend findings into certification of efficacy/safety for an entire device/ingredient or assign new grades/causality.
- Remaining uncertainty: Direct comparative/causal safety and long-term precision are unverified.
- Referenced methods: Chamgap internal interpretation boundaries, informed by M19 principles without running an official causality tool; M03 §3.2.4; Internally defined extrapolation boundaries
- Related sources: R01

### N40 · How are follow-up materials, historical candidates, versions and incomplete content review linked?

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

- Current findings: Criteria were saved and frozen before separate application. Original pending/eligible candidates remain history. Content/question-boundary review is incomplete; completion flags are false, new units are 0 and final independent counts remain unrecorded.
- Why unverified: Some original summary information is linked for production; this does not establish clinical verification/completed content review. Follow-up original materials, actual reading, changes, content review and independence decisions do not yet exist.
- Reason for missing information: Follow-up original materials, actual reading, changes, content review and independence decisions do not yet exist.
- Required materials and conditions: Review summary/criteria, new materials/original values, historical candidates and user decisions
- Materials to obtain first: Additional original materials, before/after values, versions and change-decision records
- Further research: Research directly addressing gaps in selected 12-week moisture
- Conditions for verification: Separate original information about Review summary/criteria, new materials/original values, historical candidates and user decisions from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
- Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: How are follow-up materials, historical candidates/versions and incomplete content review connected?
- Application exceptions: Do not invent current clinical review or completed publication from historical cross-checks or completed production.
- Remaining uncertainty: Follow-up original materials, actual reading, changes, content review and independence decisions do not yet exist.
- Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed splitting rules are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M04 §4.5, §4.6.3; current material-conversion limits follow review scope and internal design; M08 Table 8.2.a, M04 §4.6.3; internal application
- Related sources: R01

## Evidence and sources

### R01

Sato T, et al. Effect of 2,3-dihydro-3,5-dihydroxy-6-methyl-4H-pyran-4-one-containing lactic acid bacterial beverages on skin moisture. J Nutr Sci Vitaminol. 2025. PMID: 40151405.

[PubMed](https://pubmed.ncbi.nlm.nih.gov/40151405/)

Materials actually read: Summary read; external materials unread, access not attempted  
Findings recorded in the summary: 29.7±7.67 versus 29.7±6.19 a.u., P=0.985; change +8.05±6.85 versus +7.92±5.97, P=0.877; no 95% CI reported  
Record level: Original null comparisons of final 12-week a.u. and baseline change, distinct from positive week 4/8/whole-time findings. ± definition, sites, environment, arm denominators and CIs are unverified; the original no-CI narrative is preserved.  
Independent replication: The same Sato2025 trial/citation links both beverage arms, 220/PPS 213, sites/visits/final/change results and parent/12-week/intermediate sheets. These are not newly added independent trials/participants.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| Stored summary | Local preserved summary | Summary read | Summary read | Only acquisition/reading of the complete parent summary is established, not original paper/registry acquisition. |
| Abstract | External materials unread/needed | Unread; access not attempted | Not read | Only the original citation link is connected. External access, content verification and link testing were not attempted. |
| Full paper | External materials unread/needed | Unread; access not attempted | Not read | DOI/PMCID are not supplied; no original full text or external content was newly acquired/read. |
| Registration material | External materials unread/needed | Unread; access not attempted | Not read | Original UMIN000052867 is preserved; it is not NCT. Registry versions/content remain unread and access was not attempted. |
| Protocol | External materials unread/needed | Unread; access not attempted | Not read | Original plans for identical beverages/exposure, sites/environment, final/intermediate outcomes and harms are needed. Existence/public availability are unverified. |
| Statistical analysis plan | External materials unread/needed | Unread; access not attempted | Not read | Original plans for PPS/assignment effects, final/change contrasts, time models/multiplicity and missingness are needed. |
| Outcome tables and site/denominator/harm records | External materials unread/needed | Unread; access not attempted | Not read | Arm/visit/site, baseline/change, ± definitions, denominators/missingness and detailed harms are needed. No new calculations. |
| Funding/conflict-of-interest disclosures | External materials unread/needed | Unread; access not attempted | Not read | Original disclosures about Nissin York provision, employee/contractor and support roles remain unread. |

## Review criteria and methods

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

- M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.
- M04 [Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.
- M08 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.
- M15 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.
- M19 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

## What the statuses mean

- Met: The original content has been reviewed as meeting the conditions. This status is not used in this preparation.
- Partly verified: Some information in the stored summary was linked during preparation; clinical verification or review is not complete.
- Unverified: Required direct values, definitions or materials have not been established within the current storage and reading scope. This does not mean zero effect, no papers or failed access.
- Review incomplete: Review of existing content or actual review incomplete.
- Not reported: Used only when original materials were actually read and the outcome was judged unreported. Not used for external materials unread in this work.
- Inaccessible: Used only when an actual access attempt has a recorded failure. Not used for access that was not attempted in this work.
- Insufficient evidence for the conditions: Indicates insufficient direct materials for the relevant scope or conditions; it is not a new grade.
- Not applicable: Used when the reason it does not apply to the original question is stated.
- Conflicting data: Retains the scope of conflicting statements in original materials; it is not an arbitrary reassessment.

## Change history

2026-10-14 · Public page/materials 1.0. The public page and data were prepared from the existing 40 items. No new clinical search, verification-status change or scoring was performed.