Prevention of beta-lactam-associated diarrhea by Saccharomyces boulardii compared with placebo

Am J Gastroenterol. 1995 Mar;90(3):439-48.


Objectives: To determine the safety and efficacy of a new preventive agent for antibiotic-associated diarrhea (AAD) in patients receiving at least one beta-lactam antibiotic.

Methods: A double-blinded, placebo-controlled, parallel group study was performed in a high-risk group of hospitalized patients receiving a new prescription for a beta-lactam antibiotic and having no acute diarrhea on enrollment. Lyophilized Saccharomyces boulardii or placebo (1 g/day) was given within 72 h of the start of the antibiotic(s) and continued until 3 days after the antibiotic was discontinued, after which the patients were followed for 7 wk.

Results: Of the 193 eligible patients, significantly fewer, 7/97 (7.2%), patients receiving S. boulardii developed AAD compared with 14/96 (14.6%) on placebo (p = 0.02). The efficacy of S. boulardii for the prevention of AAD was 51%. Using a multivariate model to adjust for two independent risk factors for AAD (age and days of cephalosporin use), the adjusted relative risk was significantly protective for S. boulardii (RR = 0.29, 95% CI = 0.08, 0.98).

Conclusion: The prophylactic use of S. boulardii given with a beta-lactam antibiotic resulted in a significant reduction of AAD with no serious adverse reactions.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Anti-Bacterial Agents / adverse effects*
  • Anti-Bacterial Agents / therapeutic use
  • Clostridioides difficile / isolation & purification
  • Diarrhea / chemically induced*
  • Diarrhea / epidemiology
  • Diarrhea / prevention & control*
  • Double-Blind Method
  • Drug Utilization / trends
  • Female
  • Follow-Up Studies
  • Humans
  • Incidence
  • Male
  • Multivariate Analysis
  • Risk Factors
  • Saccharomyces*
  • Time Factors
  • Yeast, Dried / therapeutic use*
  • beta-Lactams


  • Anti-Bacterial Agents
  • beta-Lactams