Pediatric diarrhea management with probiotics supplementation: Results from a randomized controlled trial

Diarrhea remains a major cause of illness in children, and probiotics are often explored as adjunctive therapies. In this randomized, double-blind, placebo-controlled trial, 141 children aged 6 months to 6 years were assigned to receive either Limosilactobacillus reuteri FPHC2951, Bifidobacterium breve FPHC4024, or placebo alongside standard care for one month. Gut microbiota composition was analyzed before and after intervention using 16S rRNA gene sequencing. While all groups showed increased microbial α-diversity, greater enrichment of Limosilactobacillus and Bifidobacterium occurred in the probiotic groups. Clostridioides difficile levels declined across all groups. Among children receiving antibiotics, microbiota changes were notable only in the probiotic groups. However, no significant differences were observed in diarrhea duration or clinical symptoms between groups. These results suggest that probiotic supplementation can enhance gut microbial recovery during pediatric diarrhea and antibiotic exposure, although the added clinical benefits beyond standard care remain limited.