Evidence map›Paper›PMID 32623402›Full record

Trial reportJournal of Alzheimer's disease : JAD2020

Probiotic Bifidobacterium breve in Improving Cognitive Functions of Older Adults with Suspected Mild Cognitive Impairment: A Randomized, Double-Blind, Placebo-Controlled Trial.

Jinzhong Xiao, Noriko Katsumata, Francois Bernier, Kazuya Ohno, Yuki Yamauchi, Toshitaka Odamaki, Kenji Yoshikawa, Kumie Ito, Toshiyuki Kaneko

Erratum issued Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of Alzheimer's disease : JAD, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT05732935 (Fasting to Provide Energy Needed to Help Adults in Need of Cognitive Enhancement), which is not on this map. Cited by 108 papers, 15 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
108citing papers in PubMed, 15 pooled it
7.2field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05732935 nacompletednot on this mapstarted 2023, after this paper: background citation

Fasting to Provide Energy Needed to Help Adults in Need of Cognitive Enhancement (FASTING ENHANCE)

TypeinterventionalSponsorUniversity of FloridaRan2023 to 2026Enrolled45ConditionsOverweight and Obesity, Time Restricted Feeding, Alzheimer DiseaseArmsTime Restricted Eating intervention, Successful Aging Comparison Group (LEARN)
3 · Its place in the literature

Who cites it

108 citing papers in PubMed, 15 syntheses or guidelines pooled it, 186 citations in OpenAlex.

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  7. Nutrients · 2025
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  17. Efficacy and Safety ofNutrients · 2025
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48 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 2 institutions in 1 country.

Jinzhong XiaoMorinaga Milk Industry Co., Ltd., Next Generation Science Institute, Kanagawa, Japan.
Noriko KatsumataMorinaga Milk Industry Co., Ltd., Next Generation Science Institute, Kanagawa, Japan.
Francois BernierMorinaga Milk Industry Co., Ltd., Next Generation Science Institute, Kanagawa, Japan.
Kazuya OhnoMorinaga Milk Industry Co., Ltd., Next Generation Science Institute, Kanagawa, Japan.
Yuki YamauchiMorinaga Milk Industry Co., Ltd., Next Generation Science Institute, Kanagawa, Japan.
Toshitaka OdamakiMorinaga Milk Industry Co., Ltd., Next Generation Science Institute, Kanagawa, Japan.
Kenji YoshikawaHuma R & D Co. Ltd, Tokyo, Japan.
Kumie ItoNihonbashi Sakura Clinic, Tokyo, Japan.
Toshiyuki KanekoTokyo Skytree Station Medical Clinic, Tokyo, Japan.
Morinaga (Japan) · JPOsaka Nishi Clinic · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundProbiotics use has been associated with modulation of inflammation and considered as a possible intervention for CNS diseases such as mild cognitive impairment (MCI) and dementia.

objectiveWe aimed to test the effect of the probiotic strain, Bifidobacterium breve A1 (MCC1274), to restore cognition in a physically healthy, suspected MCI population.

methodsIn this randomized, double-blind, placebo-controlled trial, 80 healthy older adults suffering from MCI were divided into two even groups to receive once daily either probiotic (B. breve A1, 2×1010 CFU) or placebo for 16 weeks using a computer-generated algorithm. Cognitive functions were assessed by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and the Japanese version of the MCI Screen (JMCIS) tests before and after the study as primary and secondary endpoints, respectively.

results79 participants completed the study, and no adverse events were observed. RBANS total score was significantly improved in probiotic group compared with placebo (mean between-group difference 11.3 [95% CI 6.7 to 15.8]; p < 0.0001) after 16 weeks of consumption, in particular with significant improvement in domain scores of immediate memory, visuospatial/constructional, and delayed memory (p < 0.0001), in both intention-to-treat (ITT) analysis and per-protocol (PP) analysis. JMCIS score was also improved versus placebo in ITT analysis (p = 0.052) and PP analysis (p = 0.036).

conclusionStudy results indicate B. breve A1 is a safe and effective approach for improving memory functions of suspected MCI subjects.

Indexed as

Bifidobacterium breveAgedCognitionCognitive DysfunctionDouble-Blind MethodFemaleHumansMaleMiddle AgedProbioticsBifidobacteriumclinical trialdementiamemorymild cognitive impairmentprobiotics

Identifiers

PMID32623402
PMCPMC7592675
OpenAlexW3038957615

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.