Co-treatment with Saccharomyces boulardii appears to lower the risk of antibiotic-associated diarrhea (AAD) in adults receiving broad-spectrum antibiotics. However, it is unclear whether similar benefits occur in children, as the only published trial involving children was neither randomized nor blinded. Furthermore, conflicting data about the effects of another probiotic, Lactobacillus rhamnosus GG, suggest a different response in adult and pediatric populations, and that results observed in one population cannot be simply extrapolated to the other.
To determine if Saccharomyces boulardii prevents AAD in children.
269 children (age: 6 mo to 14 years) with otitis media and/or respiratory tract infections were enrolled in a double-blind, randomized placebo-controlled trial in which they received standard antibiotic treatment plus 250 mg of S boulardii (experimental group, n = 132) or a placebo (control group, n = 137) orally twice daily for the duration of antibiotic treatment. Analyses were based on allocated treatment and included data from 246 children.
Patients receiving S boulardii had a lower prevalence of diarrhea (≥3 loose or watery stools/day for ≥48 hours occurring during or up to 2 weeks after the antibiotic therapy) than those receiving placebo (9/119 [7.5%] vs. 29/127 [23%], relative risk, RR: 0.3, 95% confidence interval, CI: 0.2-0.7). S boulardii also reduced the risk of AAD (diarrhea caused by C difficile or otherwise unexplained diarrhea) compared with placebo (4/119 [3.4%] vs. 22/127 [17.3%], RR: 0.2; 95% CI: 0.07-0.5). No adverse events were observed.
This is the first RCT evidence that S boulardii effectively reduces the risk of AAD in children.