Prevention of β‐Lactam‐Associated Diarrhea by Saccharomyces boulardii Compared with Placebo

Objectives: To determine the safety and efficacy of a new preventive agent for antibiotic‐associated diarrhea (AAD) in patients receiving at least one β‐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 β‐lactam antibiotic and having no acute diarrhea on enrollment. Lyophilized Saccharomyces bonlardii 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% C1 = 0.08, 0.98). Conclusion: The prophylactic use of S. boulardii given with a β‐lactum antibiotic resulted in a significant reduction of AAD with no serious adverse reactions.