Saccharomyces boulardii in the prevention of antibiotic-associated diarrhoea in children: a randomized double-blind placebo-controlled trial

Aliment Pharmacol Ther. 2005 Mar 1;21(5):583-90. doi: 10.1111/j.1365-2036.2005.02356.x.

Abstract

Background: Co-treatment with Saccharomyces boulardii appears to lower the risk of antibiotic-associated diarrhoea in adults receiving broad-spectrum antibiotics.

Aim: To determine whether S. boulardii prevents antibiotic-associated diarrhoea in children.

Methods: A total of 269 children (aged 6 months 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.

Results: Patients receiving S. boulardii had a lower prevalence of diarrhoea (> or =3 loose or watery stools/day for > or =48 h occurring during or up to 2 weeks after the antibiotic therapy) than those receiving placebo [nine of 119 (8%) vs. 29 of 127 (23%), relative risk: 0.3, 95% confidence interval: 0.2-0.7]. S. boulardii also reduced the risk of antibiotic-associated diarrhoea (diarrhoea caused by Clostridium difficile or otherwise unexplained diarrhoea) compared with placebo [four of 119 (3.4%) vs. 22 of 127 (17.3%), relative risk: 0.2; 95% confidence interval: 0.07-0.5]. No adverse events were observed.

Conclusion: This is the first randomized-controlled trial evidence that S. boulardii effectively reduces the risk of antibiotic-associated diarrhoea in children.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Anti-Bacterial Agents / adverse effects*
  • Child
  • Child, Preschool
  • Diarrhea / chemically induced
  • Diarrhea / prevention & control*
  • Double-Blind Method
  • Female
  • Humans
  • Infant
  • Male
  • Probiotics / therapeutic use*
  • Saccharomyces*
  • Treatment Outcome

Substances

  • Anti-Bacterial Agents