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

INTRODUCTION: The goal of this study is to assess the efficacy and safety ofLRa05, as an adjunct to the treatment of acute watery diarrhea in children. METHODS: Eligible diarrheal children were randomized into intervention group (IG, = 57) and control group (CG, = 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, < 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%, = 0.01) and intention-to-treat analysis (66.7 vs. 41.7%, = 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, = 0.039). The intervention led to higher abundance ofand lower abundance of,, and( < 0.05). LRa05 treatment upregulated the functional genes of gut microbiota involving immunity regulation. DISCUSSION: Administration of theLRa05 at a dose of 5 × 10 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).