Effect of Probiotic Supplementation on the Duration and Severity of Acute Childhood Diarrhoea: A Double-Blind, Randomized, Placebo-Controlled Trial

Abstract

Background: Acute diarrhoea remains a leading cause of childhood morbidity and mortality in Indonesia and other low- and middle-income settings. Probiotics—particularly Lactobacillus rhamnosus GG (LGG) and Saccharomyces boulardii—have been proposed as adjuncts to oral rehydration therapy, but heterogeneous evidence and limited data from Indonesian children call for further investigation. This trial evaluated the effect of probiotic supplementation on the duration and severity of acute diarrhoea in Indonesian children. Methods: A single-centre, prospective, double-blind, parallel-group, placebo-controlled randomized trial was conducted between January 2024 and December 2025. A total of 150 children aged 6 to 60 months with acute watery diarrhoea of <72 hours' duration were enrolled and randomized 1:1 to LGG 10¹⁰ CFU twice daily plus standard care (n = 75) or matching placebo plus standard care (n = 75) for 5 days or until resolution. The primary outcome was the duration of diarrhoea from randomization to resolution. Results: Baseline characteristics were comparable. The mean duration of diarrhoea was significantly shorter in the probiotic group than in the placebo group (54.6 ± 16.8 vs 78.4 ± 22.4 hours; mean difference 23.8 hours, 95% CI 17.2–30.4; p < 0.001). Mean stool frequency on day 2 was lower (3.8 ± 1.4 vs 5.6 ± 1.8 per day; p < 0.001) and the proportion of children with diarrhoea resolution by day 3 was higher (60.0% vs 28.0%; p < 0.001). Vomiting episodes (1.2 ± 1.0 vs 1.9 ± 1.4; p = 0.001), need for intravenous rehydration (12.0% vs 26.7%; p = 0.024) and length of hospital stay (3.2 ± 1.1 vs 4.4 ± 1.3 days; p < 0.001) all favoured the probiotic arm. No serious adverse events were recorded. Conclusion: Adjunctive Lactobacillus rhamnosus GG supplementation significantly reduced the duration and severity of acute watery diarrhoea in Indonesian children, with a favourable safety profile, supporting its consideration as an adjunct to standard oral rehydration therapy and zinc supplementation