Efficacy of Saccharomyces Boulardii as an Adjunct Therapy in Children with Non-Specific Acute Diarrhea: A Double-Blind Randomized Controlled Trial

Abstract

In developing nations, non-specific acute diarrhea remains a pediatric illness. Standard treatment may not hasten recovery, indicating a need for effective adjunctive therapies. This study assessed Saccharomyces boulardii for children with non-specific acute diarrhea. A double-blind, randomized, placebo-controlled trial was conducted from November 2025 to January 2026 at three hospitals in Makassar, Indonesia. Sixty children aged 6 months to 5 years were randomized to standard therapy plus S. boulardii (250 mg twice daily for 5 days) or placebo. Primary outcomes were diarrhea frequency and stool consistency. Baseline characteristics were homogeneous (p > 0.05). The intervention group showed a significantly faster reduction in diarrhea frequency from Day 2 to Day 5 than controls (p < 0.05). Stool consistency also improved faster, with 96.7% achieving solid stool by Day 5 versus 100% remaining soft in controls (p < 0.001). Median diarrhea duration was 3 days in both groups (p = 0.584). Adjunctive S. boulardii accelerated daily improvement without shortening duration.