# IDCC 1201 · Four-week PSG sleep efficiency — Evidence Check Verdict 2967 · 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: 2026-10-13 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: 80 adults with sleep disturbance randomized; severe insomnia and diagnosed sleep disorders excluded; PP78 analyzed - Ingredient, formulation and route: Bacillus coagulans IDCC 1201 trial capsules - Dose: Research exposure: 5 billion CFU/day, one hour before bedtime, four weeks; not intake guidance - Comparator: Trial placebo capsules; original composition/matching details unread - Measured outcome: Change from baseline to week 4 in PSG sleep efficiency; changes, between-group difference and baseline-adjusted P distinguished - Duration: Four-week research exposure and results; sustained effects after completion and long-term safety unverified - Questions outside this scope: No new formulations, populations, clinical effects, CI, verdicts, independence certification, participant totals, implementation or treatment instructions are created ## Checklist items ### N01 · What are the selected question and its subclaim verdict? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: The selected subclaim is improved four-week PSG sleep efficiency, originally graded C, with a note that the baseline-adjusted analysis was also positive but this is one short manufacturer trial. The parent verdict is C with 50 points. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: The selected row has no score, status or axes. Do not fill these with parent values or create a new verdict. - Required materials and conditions: Original wording, subclaim grade and note for the four-week PSG sleep-efficiency question - Materials to obtain first: Original selected row and parent verdict - Further research: Present the original subclaim verdict separately from parent context - Conditions for verification: Original wording, subclaim grade and note for the four-week PSG sleep-efficiency question; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N02 · Are sleep disturbance and diagnosed sleep disorders distinguished in the trial population? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: The record describes adults with sleep disturbance and exclusion of severe insomnia and diagnosed sleep disorders. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Detailed age, diagnoses, baseline conditions and recruitment criteria remain unread. Do not extend the result to treatment of diagnosed insomnia or all adults. - Required materials and conditions: Actual eligibility, exclusions, baseline characteristics and diagnostic criteria - Materials to obtain first: Eligibility, exclusion and baseline-characteristics tables - Further research: Distinguish included participants from excluded sleep disorders - Conditions for verification: Actual eligibility, exclusions, baseline characteristics and diagnostic criteria; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N03 · What exactly are the intervention strain, research exposure and duration? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: The research combination is described as Bacillus coagulans IDCC 1201, 5 billion CFU/day, one hour before bedtime, for four weeks. Active and placebo capsules were used. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: This preserves research identity and is not intake guidance or a product recommendation. Equivalence of other strains, exposures, formulations or durations is not established. - Required materials and conditions: Original IDCC 1201 strain, units, research exposure and duration - Materials to obtain first: Trial product, strain and exposure specifications - Further research: Preserve the research combination and its applicability limits - Conditions for verification: Original IDCC 1201 strain, units, research exposure and duration; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N04 · Are materials available on placebo composition and the feasibility of blinding? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: The original summary describes a double-blind placebo-controlled trial and company provision of active and placebo capsules. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Capsule composition, appearance and sensory matching, blinding success, batches and storage details remain unread. - Required materials and conditions: Placebo ingredients, appearance, sensory properties, packaging and blinding procedures - Materials to obtain first: Active/placebo specifications and blinding procedures - Further research: Present product provision separately from actual blinding characteristics - Conditions for verification: Placebo ingredients, appearance, sensory properties, packaging and blinding procedures; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N05 · Are balance and changes in sleep behavior, medication and other exposures known? Verification status: Unverified Reading scope: Summary read; related external material unread - Current findings: The preserved summary provides an intervention-versus-placebo comparison but no details of concurrent sleep exposures, lifestyle changes or concomitant medication. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Equality of concurrent exposures is not certified. No sleep or treatment-change instructions are written. - Required materials and conditions: Concurrent exposures, medication, lifestyle changes, adherence and deviations - Materials to obtain first: Concurrent-exposure, intervention-adherence and deviation tables - Further research: Present concurrent exposures and actual intervention deviations over the same period - Conditions for verification: Concurrent exposures, medication, lifestyle changes, adherence and deviations; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N06 · Are details of randomization, concealment and blinding verified? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: The material describes a double-blind randomized placebo-controlled trial assigning 80 adults, 40 per group. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Original methods for sequence generation, concealment, code release and blinding by role remain externally unread. The parent B2 axis is not converted into a new assessment. - Required materials and conditions: Random sequence, allocation concealment and blinding by role - Materials to obtain first: Original randomization, concealment and blinding methods - Further research: Distinguish design labels from implementation materials - Conditions for verification: Random sequence, allocation concealment and blinding by role; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N07 · Are randomized and per-protocol analysis denominators distinguished? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: The record gives 80 randomized, 40/40, and a per-protocol analysis of 78, 39/39. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Do not convert PP78 into all 80 assigned or everyone completing the trial. Reasons for analysis exclusions and group-specific flow are absent from the summary. - Required materials and conditions: Allocation, completion, analysis, exclusions and flow by group - Materials to obtain first: Allocation, follow-up, PP and other analysis-population flow - Further research: Present allocation and analysis denominators separately - Conditions for verification: Allocation, completion, analysis, exclusions and flow by group; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N08 · Is information on PP exclusions, missing data and the effect of interest sufficient? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: The current efficacy summary uses results for PP78. The existing research description and evidence list explicitly identify PP. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Do not elevate PP results to effects in everyone assigned. Exclusion reasons, ITT results and sensitivity analyses remain unread. - Required materials and conditions: PP definition, exclusion reasons, missing-data handling and other analysis results - Materials to obtain first: Analysis-population definitions, missing-data handling and sensitivity analyses - Further research: Present the scope of analysis choices and their implications by material - Conditions for verification: PP definition, exclusion reasons, missing-data handling and other analysis results; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N09 · Is the baseline sleep-efficiency imbalance retained? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: Baseline sleep efficiency is recorded as differing: 75.75% versus 85.08%, P=0.049. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Do not describe baseline imbalance as removed or newly calculate regression effects or causal magnitudes. - Required materials and conditions: Group-specific baseline values and their connection to adjusted analysis - Materials to obtain first: Baseline characteristics and prespecified adjustment model - Further research: Present baseline imbalance, changes and adjusted results separately - Conditions for verification: Group-specific baseline values and their connection to adjusted analysis; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N10 · What measurement does PSG sleep efficiency represent? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: The existing product explanation describes the proportion of time in bed actually spent asleep. The evidence endpoint is change from baseline to week 4 in PSG sleep efficiency. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: PSG scoring rules, equipment, scorers and original total-sleep-time and time-in-bed values remain unread. Do not combine this with subjective insomnia scales. - Required materials and conditions: Definition, measurement and scoring of objective sleep efficiency - Materials to obtain first: PSG measurement/scoring manuals and original measurement tables - Further research: Present the objective measure separately from subjective scales - Conditions for verification: Definition, measurement and scoring of objective sleep efficiency; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N11 · Are the four-week time point and measurement-night or repeated-measurement denominators distinguished? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: The summary specifies baseline to four weeks. It gives no details of the number of measurement nights or handling of repeated measurements. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Do not count nights, repeated measurements, groups or time points as new participants or independent trials. - Required materials and conditions: Baseline/week-4 schedule, number of nights, averaging and missing-data methods - Materials to obtain first: PSG schedule, measurement-night and repeated-measurement materials - Further research: Distinguish people from measurement nights and time points - Conditions for verification: Baseline/week-4 schedule, number of nights, averaging and missing-data methods; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N12 · Are group changes and the meaning of the ± notation preserved? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: Original values are +13.71±21.14 versus -0.15±13.35 percentage points. Do not convert these into final absolute sleep efficiency. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: The summary does not specify whether ± denotes SD or SE, so no label is assigned. Do not construct final group values by adding changes to baseline. - Required materials and conditions: Original definitions of group changes and uncertainty notation - Materials to obtain first: Original table defining group changes and ± notation - Further research: Present changes, final values, dispersion and precision separately - Conditions for verification: Original definitions of group changes and uncertainty notation; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N13 · What between-group difference and interval are given in the original? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: For PP78, the original between-group difference is +13.86 percentage points, P=0.002; the summary states that a confidence interval was not reported. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Do not calculate new CI, effects or between-group differences. Absence of an effect interval does not establish precision. - Required materials and conditions: Between-group effect, interval, test and analysis population - Materials to obtain first: Original result table, effect estimate and confidence interval - Further research: Present the directly reported difference together with the absent CI - Conditions for verification: Between-group effect, interval, test and analysis population; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N14 · Are baseline-adjusted ranked ANCOVA results distinguished from the original difference? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: The preserved summary states that baseline-adjusted ranked ANCOVA was also positive, P=0.015. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: The adjusted effect and CI are absent from the summary. Do not automatically use the original +13.86-percentage-point difference as the adjusted estimate. - Required materials and conditions: Adjustment model, adjusted estimate, interval and P value - Materials to obtain first: Ranked ANCOVA model and adjusted-effect table - Further research: Present the original difference separately from the baseline-adjusted test - Conditions for verification: Adjustment model, adjusted estimate, interval and P value; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N15 · Are prespecified criteria available for minimum important difference and clinical importance? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: The existing verdict rationale states that there was no prespecified minimum important difference and that the effect CI was not reported. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Do not invent a clinical important difference, sleep normalization or perceived treatment effect. - Required materials and conditions: Prespecified importance criteria and supporting grounds for PSG sleep efficiency - Materials to obtain first: Prespecified importance criteria and links to clinical outcomes - Further research: Present statistical results separately from clinical importance - Conditions for verification: Prespecified importance criteria and supporting grounds for PSG sleep efficiency; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N16 · Are participant enrollment, trial completion and official registration dates separated? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: Participant enrollment began 2025-02-03; the trial ended 2025-07-02; CRIS KCT0011568 registration was 2026-02-02. The preserved summary describes registration seven months after trial completion. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Do not change registration into preregistration before recruitment. Do not calculate new durations or date differences. - Required materials and conditions: Actual dates of each event and registration history - Materials to obtain first: Original CRIS registration, change history and recruitment records - Further research: Present recruitment, completion and registration as separately dated events - Conditions for verification: Actual dates of each event and registration history; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N17 · Does a registration number establish actual reading? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: The existing registration-identifier record contains KCT0011568, and the research narrative identifies CRIS registration. Do not relabel this as NCT registration because of the original storage field name. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Official registration URL, document and revision history remain unread here; an identifier alone does not certify prespecification. - Required materials and conditions: Distinction between KCT0011568 identity and access to or contents of the original registration - Materials to obtain first: Official KCT0011568 registration document - Further research: Distinguish the preserved registration identifier from actual reading status - Conditions for verification: Distinction between KCT0011568 identity and access to or contents of the original registration; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N18 · Was the paper-labeled primary endpoint independently verified prospectively? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: The preserved research narrative states that registration after trial completion weakens independent prospective verification of the paper-labeled primary endpoint. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Do not elevate PSG efficiency to a prospectively confirmed endpoint through retrospective registration alone. - Required materials and conditions: Materials comparing the pre-recruitment plan with the paper’s primary-endpoint label - Materials to obtain first: Pre-recruitment protocol/SAP and registration/paper endpoints - Further research: Present the paper’s endpoint label separately from planning time - Conditions for verification: Materials comparing the pre-recruitment plan with the paper’s primary-endpoint label; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N19 · Can plans for multiplicity, additional outcomes and analysis selection be verified? Verification status: Unverified Reading scope: Summary read; related external material unread - Current findings: The preserved summary includes PSG efficiency, baseline adjustment and some safety information, but no detailed complete plan, multiple-comparison adjustment or analysis selection. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Do not newly certify plans or statistical significance for other outcomes. - Required materials and conditions: Prespecified hierarchy and changes for all analyses, endpoints and adjustments - Materials to obtain first: Protocol, SAP, endpoint list and revision history - Further research: Present the prespecified hierarchy of efficacy, additional and safety analyses - Conditions for verification: Prespecified hierarchy and changes for all analyses, endpoints and adjustments; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N20 · Are subjective insomnia improvement and PSG sleep efficiency distinguished? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: The existing counterpoint states that subjective insomnia improvement and PSG sleep efficiency are different endpoints. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Do not fill subjective sleep quality, overall insomnia or everyday-function efficacy with a positive objective measure. - Required materials and conditions: Original results and measurement definitions for each objective/subjective endpoint - Materials to obtain first: Endpoint-specific original results for subjective scales and daily functioning - Further research: Present different sleep outcomes as separate questions - Conditions for verification: Original results and measurement definitions for each objective/subjective endpoint; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N21 · Was REM-related sleep efficiency combined with overall PSG sleep efficiency? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: The existing counterview mentions a meta-analysis of REM-related sleep efficiency. The current IDCC 1201 trial endpoint is change from baseline to four weeks in PSG sleep efficiency. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Do not establish REM-related measures as equivalent to overall PSG measures or combine different effects. - Required materials and conditions: Endpoint definitions and measurement scope in the current trial and review - Materials to obtain first: Review endpoint definitions and included-trial tables - Further research: Distinguish overall-sleep and REM-related measures and strains - Conditions for verification: Endpoint definitions and measurement scope in the current trial and review; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01, R02 ### N22 · What is the actual material scope of the unidentified meta-analysis context? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: The preserved summary describes a null REM-related sleep-efficiency result from three trials in a 39-RCT meta-analysis: MD 1.64 percentage points, 95% CI -0.35 to 3.64. The review bibliography is not provided. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Do not certify 39 or three as directly read or independent-replication counts here. Leave the external review document and inclusion relationships unverified. - Required materials and conditions: Bibliography, included trials, strains and original endpoints for the 39-RCT review - Materials to obtain first: Exact bibliography, included trials and result tables of the mentioned review - Further research: Present unidentified preserved context separately from the identified trial report - Conditions for verification: Bibliography, included trials, strains and original endpoints for the 39-RCT review; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R02 ### N23 · Were IDCC 1201 results extended to probiotics generally? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: The summary states that null whole-group trials of other strains address a different question and that these results cannot be extended to probiotics generally or treatment of diagnosed insomnia. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Do not elevate other-strain or other-endpoint results to equivalence or independent replication of IDCC 1201. - Required materials and conditions: Direct comparisons and applicability evidence by strain, product, population and duration - Materials to obtain first: Direct replication or comparison for the same strain, product and population - Further research: Preserve strain-specific applicability boundaries as separate questions - Conditions for verification: Direct comparisons and applicability evidence by strain, product, population and duration; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01, R02 ### N24 · Were the paper, registration and related context counted as independent repeat trials? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: The directly identified trial bibliography is one Kim et al. 2026 paper linked to KCT0011568. The preserved summary contains only one selected subclaim row. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Do not count the paper, registration, PSG time points, review or parent summary as new independent trials or sum participants. Confirmed independent-trial and participant totals remain unrecorded. - Required materials and conditions: Connections and overlap among current report, registration and review context - Materials to obtain first: Connections among papers, registration and analyses of the same trial - Further research: Distinguish report entries from trial and participant units - Conditions for verification: Connections and overlap among current report, registration and review context; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01, R02 ### N25 · Are research funding and active/placebo product provision distinguished? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: Ildong Bioscience provided research funding and active/placebo capsules; the original summary describes full manufacturer funding. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Do not change funding or product support into public or independent support. Support contracts, product details and data rights remain unread. - Required materials and conditions: Original disclosures of funding, products, contracts and company roles - Materials to obtain first: Funding/product disclosures and contract/role specifications - Further research: Present funding, product supply and involvement in results as separate items - Conditions for verification: Original disclosures of funding, products, contracts and company roles; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N26 · Are the names and relationships of company employee authors preserved? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: Hayoung Kim, Jinho Lee, Won Yeong Bang, Han Bin Lee and Jin Seok Moon are recorded as company employees in the preserved summary. The evidence list records five employee authors. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Do not remove names or employee relationships or certify all authors as independent. Full author-specific contributions remain unread in the original paper. - Required materials and conditions: Employee authors, affiliations, contributions and other conflict disclosures - Materials to obtain first: Author affiliation, contribution and COI disclosures - Further research: Present employee relationships separately from each author’s actual roles - Conditions for verification: Employee authors, affiliations, contributions and other conflict disclosures; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N27 · Are the company’s limited role denials distinguished from overall independence? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: The summary states that the paper declared no company involvement in recruitment, collection, endpoint assessment or statistical analysis. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Do not extend denial of these four roles to no involvement in design, outsourced analysis, medical writing, publication costs, publication control or everything else, or to independent-replication certification. - Required materials and conditions: Materials on recruitment, collection, endpoint assessment, statistical analysis, design, writing and publication roles - Materials to obtain first: Company/author roles and data/publication-rights disclosures - Further research: Distinguish disclosed role denials from involvement that remains unverified - Conditions for verification: Materials on recruitment, collection, endpoint assessment, statistical analysis, design, writing and publication roles; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N28 · Is the observation scope of four-week adverse-event nonreporting clear? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: The safety summary states that no significant adverse events or intervention-related side effects were reported during four weeks. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Do not convert this into zero events, complete collection for everyone or established product safety. Detailed harms tables and denominators remain unread. - Required materials and conditions: Event definitions, collection methods, denominators by group and discontinuations - Materials to obtain first: Group-specific harms/discontinuation tables and collection methods - Further research: Present reporting scope and actual collection/exposure denominators - Conditions for verification: Event definitions, collection methods, denominators by group and discontinuations; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Supplementary condition showing limits of harms/safety information separately from efficacy - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N29 · Is systolic-pressure change the same outcome as sleep efficiency or confirmed harm? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: The original safety narrative records a between-group P=0.019 for systolic-pressure change, while values were within the normal range. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Original values, direction, CI and event counts are absent from the summary. Do not establish new hypertension harm or clinical harmlessness or combine this with PSG efficacy. - Required materials and conditions: Values, intervals, baseline, time points and event information for blood-pressure changes - Materials to obtain first: Original blood-pressure results and baseline/group denominator tables - Further research: Present blood-pressure measures separately from adverse events and sleep efficiency - Conditions for verification: Values, intervals, baseline, time points and event information for blood-pressure changes; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Supplementary condition showing limits of harms/safety information separately from efficacy - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N30 · Can long-term or rare harms and safety in other populations be assessed? Verification status: Unverified Reading scope: Summary read; related external material unread - Current findings: The preserved summary explicitly states that four weeks is short for assessing long-term safety. The parent safety-caution label is the original record. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Do not extend a short trial to long-term/rare harms or safety in excluded patients with diagnoses. - Required materials and conditions: Long-term exposure/follow-up, vulnerable populations and rare-event materials - Materials to obtain first: Long-term follow-up, rare events and population-specific harms materials - Further research: Present long-term safety gaps separately from efficacy - Conditions for verification: Long-term exposure/follow-up, vulnerable populations and rare-event materials; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Supplementary condition showing limits of harms/safety information separately from efficacy - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N31 · Do four-week results show sustained effects after completion or sleep-disorder prevention? Verification status: Unverified Reading scope: Summary read; related external material unread - Current findings: The directly preserved trial exposure and PSG results cover four weeks. The summary has no results for sustained sleep efficiency or disease prevention after completion. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Do not fill long-term persistence, treatment of diagnosed insomnia or treatment replacement with a four-week efficiency change. - Required materials and conditions: Direct follow-up, sustained-effect and clinical-outcome materials after completion - Materials to obtain first: Post-completion PSG and clinical-outcome follow-up materials - Further research: Present treatment-period and post-completion sustained results as separate questions - Conditions for verification: Direct follow-up, sustained-effect and clinical-outcome materials after completion; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N32 · Are summary reading and unread external abstract, full text, registration and plans distinguished? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: The entire preserved summary was read. The original PubMed URL in the citation list is linked; external abstract, full text, registration, protocol and SAP are marked unread. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Link existence or passages quoted in the original do not establish external reading or completed content review here. Do not invent a URL for the unidentified review. - Required materials and conditions: Original form, actual reading and access status by material type - Materials to obtain first: Actual paper, registration/plans and mentioned-review materials - Further research: Mark summary reading separately from unread external materials - Conditions for verification: Original form, actual reading and access status by material type; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01, R02 ### N33 · Are parent Korean/English prose, axes, reference date and correction history preserved in original form? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: Parent Korean/English prose, axes, the 2026-08-26 reference date, the empty corrections array and deliberation string, and the selected row are preserved in the complete existing summary. The reference date is not used as the current review date. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: The selected row’s absent score, status and axes remain absent; parent C with 50 points and B2/I0 axes are not recalculated as a new verdict. - Required materials and conditions: Whole copies of selected row, parent record and historical dates - Materials to obtain first: Original review summary and condition/application preparation events - Further research: Separate existing verdict/correction history from preparation date and existing content review - Conditions for verification: Whole copies of selected row, parent record and historical dates; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01 ### N34 · Are the preserved candidate’s review-pending/eligibility markers separated from the current preparation event? Verification status: Partly verified Reading scope: Summary read; related external material unread - Current findings: The existing subclaim unit is prepared, distinguishing question and verdict record. Candidate review-pending, production-eligibility and independence markers are preserved as historical selection metadata. - Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict - Reason for missing information: Content review belongs to the user. Do not invent completed model, content or boundary review; retain zero new structural units and unrecorded confirmed independent-trial/participant totals. - Required materials and conditions: Existing candidate metadata, preparation, review and independence status - Materials to obtain first: Existing selection and freeze/application preparation events - Further research: Link preparation completion separately from existing content-review status - Conditions for verification: Existing candidate metadata, preparation, review and independence status; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials - Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score - Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations - Remaining uncertainty: Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed - Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions - Related sources: R01, R02 ## Evidence and sources ### R01 Kim H, et al. Efficacy and Safety of Bacillus coagulans IDCC 1201 for Sleep Improvement in Adults with Sleep Disturbance. Nutrients. 2026;18:1525. PMID: 42196985. [PubMed](https://pubmed.ncbi.nlm.nih.gov/42196985/) Materials actually read: Stored summary read; external abstracts, full texts, registrations and plans unread Findings recorded in the summary: +13.71±21.14 versus -0.15±13.35 percentage points; difference +13.86 percentage points, P=0.002; baseline-adjusted P=0.015; CI not reported Record level: PP changes, original between-group difference and baseline-adjusted P; adjusted effect and CI are separate gaps Independent replication: Connections among the paper, registration, analyses and parent/selected summaries of the same IDCC 1201 trial; unidentified-review bibliography context slot; independence of included trials, inclusion of the current trial and overlap unverified | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Stored summary | Summary read | Stored summary read | Summary read | Material slot, not an independent-trial count, reading certification or link-check result; URLs absent from original materials are not invented | | External abstract | Not read | External material unread | Not read | Material slot, not an independent-trial count, reading certification or link-check result; URLs absent from original materials are not invented | | External full text | Not read | External material unread | Not read | Material slot, not an independent-trial count, reading certification or link-check result; URLs absent from original materials are not invented | | Original registration | Not read | External material unread | Not read | Material slot, not an independent-trial count, reading certification or link-check result; URLs absent from original materials are not invented | | Protocol/SAP | Not read | External material unread | Not read | Material slot, not an independent-trial count, reading certification or link-check result; URLs absent from original materials are not invented | ### R02 Unidentified 39-RCT meta-analysis context mentioned in the preserved summary Materials actually read: The preserved summary describing this context was read; the external review remains unread Findings recorded in the summary: Null whole-group trials of other strains do not address exactly the same question. The preserved 39-RCT meta-analysis context describes a null REM-related sleep-efficiency result in three trials: MD 1.64 percentage points, 95% CI -0.35 to 3.64. It therefore cannot be generalized to probiotics improving sleep. Record level: Original narrative of the REM-related three-trial MD and 39-RCT context preserved; no new trial-count certification or effect combination Independent replication: Connections among the paper, registration, analyses and parent/selected summaries of the same IDCC 1201 trial; unidentified-review bibliography context slot; independence of included trials, inclusion of the current trial and overlap unverified | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Stored summary | Summary read | Stored summary read | Summary read | Material slot, not an independent-trial count, reading certification or link-check result; URLs absent from original materials are not invented | | External abstract | Not read | External material unread | Not read | Material slot, not an independent-trial count, reading certification or link-check result; URLs absent from original materials are not invented | | External full text | Not read | External material unread | Not read | Material slot, not an independent-trial count, reading certification or link-check result; URLs absent from original materials are not invented | | Original registration | Not read | External material unread | Not read | Material slot, not an independent-trial count, reading certification or link-check result; URLs absent from original materials are not invented | | Protocol/SAP | Not read | External material unread | Not read | Material slot, not an independent-trial count, reading certification or link-check result; URLs absent from original materials are not invented | ## 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. · Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed. - 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. · Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed. - 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. · Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed. - 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. · Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed. - 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. · Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed. ## What the statuses mean - Partly verified: Some information exists in the preserved review summary; detailed original materials remain unverified. This does not certify a passed review or clinical efficacy. - Unverified: Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety - Review incomplete: Review of existing content incomplete - Met: Use only within the relevant conditions after existing content review; no automatic designation in this preparation - Not reported: Distinguish only within materials actually read; do not turn unread external materials into unreported findings - Inaccessible: Not applied during this preparation because actual access was not tested - Not applicable: Use with a reason for non-applicability based on an explicit question boundary - Conflicting data: Judge after actual material comparison; review was not performed during this preparation - Insufficient evidence for the conditions: Do not use as a clinical grade encompassing currently unread materials ## Change history 2026-10-13 · Public page/materials 1.0. Public views and materials were prepared from the existing 34 items. No new clinical search, verification-status changes or scoring were performed.