Evidence map›Paper›PMID 38467857›Full record

Trial reportEuropean journal of clinical nutrition2024

Adjudicative efficacy of Bifidobacterium animalis subsp. lactis BLa80 in treating acute diarrhea in children: a randomized, double-blinded, placebo-controlled study.

Ke Chen, Shanshan Jin, Yu Ma, Limei Cai, Ping Xu, Yang Nie, Li Luo, Qinghua Yu, Yang Shen, Zengyuan Zhou and 1 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in European journal of clinical nutrition, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07505329 (An Intervention Study in Healthy Infants Aged 0-6 Months With Probiotics Lacticaseibacillus Rhamnosus LRa05), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT07505329 nanot yet recruitingnot on this mapstarted 2026, after this paper: background citation

An Intervention Study in Healthy Infants Aged 0-6 Months With Probiotics Lacticaseibacillus Rhamnosus LRa05 (LRa05) and Bifidobacterium Animalis Subsp. Lactis BLa80 (BLa80) vs. Placebo, for Promoting Gut Microbiome Development.

TypeinterventionalSponsorUniversity College CorkRan2026 to 2028Enrolled300ConditionsLess Than 3 Months Old, Healthy InfantsArmsPlacebo (maltodextrin), Probiotic
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Efficacy and safety ofFrontiers in cellular and infection microbiology · 2025
    Pooled it
  2. Trial
  3. Review
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. Frontiers in nutrition · 2024
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Ke ChenDepartment of Nutrition, Chengdu Women's and Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China. kechen@uestc.edu.cn.ORCID http://orcid.org/0000-0001-7455-0900
Shanshan JinDepartment of Nutrition, Chengdu Women's and Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.ORCID http://orcid.org/0000-0001-5435-0530
Yu MaDepartment of Neonatology, Dayi Maternal and Child Health Care Hospital, Chengdu, China.
Limei CaiDepartment of Neonatology, Qingbaijiang Maternal and Child Health Care Hospital, Chengdu, China.
Ping XuDepartment of Child Health Care, Qingbaijiang Maternal and Child Health Care Hospital, Chengdu, China.
Yang NieDepartment of Child Health Care, Chongzhou Maternal and Child Health Care Hospital, Chengdu, China.
Li LuoDepartment of Pediatrics, Dayi Maternal and Child Health Care Hospital, Chengdu, China.
Qinghua YuLaboratory of Microbiology, Immunology and Metabolism, Diprobio (Shanghai) Co., Limited, Shanghai, China.
Yang ShenLaboratory of Microbiology, Immunology and Metabolism, Diprobio (Shanghai) Co., Limited, Shanghai, China.
Zengyuan ZhouDepartment of Nutrition, Chengdu Women's and Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.
Changqi LiuSchool of Exercise and Nutritional Sciences, San Diego State University, San Diego, CA, USA.ORCID http://orcid.org/0000-0001-6526-5024

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The goal of this study is to assess the efficacy and safety of Bifidobacterium animalis subsp. lactis BLa80, as an adjunct treatment for diarrhea in children with a randomized, double-blinded, placebo-controlled study design. Eligible diarrheal children, aged 0-3 years without the need for antibiotic treatment based on clinical diagnosis when recruited, were randomized into the intervention group (IG, n = 58, with probiotic) or the control group (CG, n = 53, placebo). The primary assessment was the duration of diarrhea. Fecal samples were collected for biochemical index measurement, analysis of gut microbiome composition, and prediction of gene family abundances. The total duration of diarrhea in the IG (122.6 ± 13.1 h) was significantly shorter than in the CG (148.4 ± 17.6 h, p < 0.001). More children in the IG showed improvements in diarrhea compared to the CG, both in intention-to-treat analysis (81.7% vs. 40.0%, p < 0.001) and per protocol analysis (84.4% vs 45.3%, p < 0.001). Cathelicidin level in the IG was significantly higher than that in the CG after the intervention (4415.00 ± 1036.93 pg/g vs. 3679.49 ± 871.18 pg/g, p = 0.0175). The intervention led to an increased abundance of Bifidobacterium breve and Collinsella aerofaciens species, higher alpha-diversity (p < 0.05), and enrichment of functional genes in the gut microbiota related to immunity regulation. Administration of BLa80 at a dose of 5 × 10

Indexed as

Bifidobacterium animalisDiarrheaFecesGastrointestinal MicrobiomeProbioticsAcute DiseaseCathelicidinsChild, PreschoolDouble-Blind MethodFemaleHumansInfantInfant, NewbornMaleTreatment OutcomeCathelicidins

Identifiers

PMID38467857
PMCPMC11182741

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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.