Lacticaseibacillus rhamnosus LRa05 in the treatment of acute diarrhea in children: a randomized controlled trial.

2024-11-15
Frontiers in nutrition 11
- Ke Chen
- Kaihong Zeng
- Shanshan Jin
- Yu Ma
- Limei Cai
- Ping Xu
- Yang Nie
- Li Luo
- Qinghua Yu
- Changqi Liu

PubMed: 39619284
DOI: 10.3389/fnut.2024.1479186

Study Design

Type: Randomized Controlled Trial (RCT)
Population: children aged 0-3 years with acute watery diarrhea
Methods: Eligible diarrheal children were randomized into intervention group (IG, n = 57) and control group (CG, n = 54), and given probiotics or placebo, respectively. Administration of Lacticaseibacillus rhamnosus LRa05 at a dose of 5 × 10^9 CFU/day.

Introduction

The goal of this study is to assess the efficacy and safety of Lacticaseibacillus rhamnosus LRa05, as an adjunct to the treatment of acute watery diarrhea in children.

Methods

Eligible diarrheal children were randomized into intervention group (IG, n = 57) and control group (CG, n = 54), and given probiotics or placebo, respectively.

Results

The total duration of diarrhea in the IG (121.4 ± 13.7 h) was significantly shorter than that in the CG (143.9 ± 19.8 h, p < 0.001). More children in the IG showed improvements in diarrhea than those in the CG for both per protocol analysis (70.2 vs. 46.3%, p = 0.01) and intention-to-treat analysis (66.7 vs. 41.7%, p = 0.003). The LL-37 levels in the IG was markedly higher than that in the CG after the intervention (4349.35 ± 1143.86 pg./g vs. 3682.49 ± 869.21 pg./g, p = 0.039). The intervention led to higher abundance of Bifidobacterium longum and lower abundance of Enterococcus faecium, Lactobacillus rhamnosus, and Bacteroides fragilis (p < 0.05). LRa05 treatment upregulated the functional genes of gut microbiota involving immunity regulation.

Discussion

Administration of the Lacticaseibacillus rhamnosus LRa05 at a dose of 5 × 10⁹ CFU/day to children aged 0-3 years resulted in shorter duration of diarrhea, faster improvement in fecal consistency, and beneficial changes in gut microbiome composition and gene functions.

Clinical trial registration

The present study has been approved and registered in the Chinese Clinical Trial Registration Center with the registration number of ChiCTR2100053700 (https://www.chictr.org.cn/showproj.html?proj=141082).

Research Insights

Lactobacillus rhamnosus LRa05→Improved Gut Flora Modulation
The intervention led to higher abundance of Bifidobacterium longum and lower abundance of Enterococcus faecium, Lactobacillus rhamnosus, and Bacteroides fragilis (p < 0.05). LRa05 treatment upregulated the functional genes of gut microbiota involving immunity regulation.
Effect
Beneficial
Effect size
Moderate
Dose
5 × 10^9 CFU/day
Lactobacillus rhamnosus LRa05→Increased LL-37 Levels
The LL-37 levels in the IG was markedly higher than that in the CG after the intervention (4349.35 ± 1143.86 pg./g vs. 3682.49 ± 869.21 pg./g, p = 0.039).
Effect
Beneficial
Effect size
Small
Dose
5 × 10^9 CFU/day
Lactobacillus rhamnosus LRa05→Reduced Diarrhea Rate
More children in the IG showed improvements in diarrhea than those in the CG for both per protocol analysis (70.2 vs. 46.3%, p = 0.01) and intention-to-treat analysis (66.7 vs. 41.7%, p = 0.003).
Effect
Beneficial
Effect size
Moderate
Dose
5 × 10^9 CFU/day
Lactobacillus rhamnosus LRa05→Reduced Duration of Diarrhea
The total duration of diarrhea in the IG (121.4 ± 13.7 h) was significantly shorter than that in the CG (143.9 ± 19.8 h, p < 0.001).
Effect
Beneficial
Effect size
Large
Dose
5 × 10^9 CFU/day
Lactobacillus rhamnosus LRa05→Resolution of Diarrhea
More children in the IG showed improvements in diarrhea than those in the CG for both per protocol analysis (70.2 vs. 46.3%, p = 0.01) and intention-to-treat analysis (66.7 vs. 41.7%, p = 0.003).
Effect
Beneficial
Effect size
Moderate
Dose
5 × 10^9 CFU/day