Adjudicative efficacy of Bifidobacterium animalis subsp. lactis BLa80 in treating acute diarrhea in children: a randomized, double-blinded, placebo-controlled study.
- 2024-03-11
- European journal of clinical nutrition 78(6)
- Ke Chen
- Shanshan Jin
- Yu Ma
- Limei Cai
- Ping Xu
- Yang Nie
- Li Luo
- Qinghua Yu
- Yang Shen
- Zengyuan Zhou
- Changqi Liu
- PubMed: 38467857
- DOI: 10.1038/s41430-024-01428-6
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Sample size
- n = 58
- Population
- diarrheal children, aged 0-3 years without the need for antibiotic treatment based on clinical diagnosis when recruited
- Methods
- randomized, double-blinded, placebo-controlled study design; intervention group (n=58, with probiotic Bifidobacterium animalis subsp. lactis BLa80) vs control group (n=53, placebo); dose of 5 × 10^9 CFU/day
- Blinding
- Double-blind
- Rigorous Journal
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 × 109 CFU/day resulted in a shorter duration of diarrhea and alterations in gut microbiome composition and gene functions.
Research Insights
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).
- Effect
- Beneficial
- Effect size
- Moderate
- Dose
- 5 × 10^9 CFU/day
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).
- Effect
- Beneficial
- Effect size
- Large
- Dose
- 5 × 10^9 CFU/day
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).
- Effect
- Beneficial
- Effect size
- Large
- Dose
- 5 × 10^9 CFU/day