Efficacy and Safety of Saccharomyces boulardii in Acute Rotavirus Diarrhea: Double Blind Randomized Controlled Trial from a Developing Country

Abstract

Objective: To study the efficacy and safety of Saccharomyces boulardii (SB) in acute childhood rotavirus diarrhea.

Methods: Children (3 months to 5 years) with WHO-defined acute watery diarrhea and stool rotavirus positive (n = 60) were randomized into intervention (n = 30) and control (n = 30) groups. The intervention group received SB (500 mg/day) for 5 days.

Results: The median duration (hours) of diarrhea was significantly shorter in the intervention group (60 vs. 89; 95% CI: -41.2 to - 16.8). A significantly shorter duration of hospitalization (74 vs. 91; 95% CI: -33.46 to - 0.54) was also seen in the intervention group, but no significant difference was seen for fever and vomiting. There was also no difference between the two groups in the proportion of children requiring parenteral rehydration and persistence of diarrhea lasting beyond day 7. There was no report of any adverse events.

Conclusions: The present trial showed that SB is effective and safe in acute rotavirus diarrhea.

Keywords: Reoviridae; acute gastroenteritis; pediatric; probiotics.