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

• Published in: Alimentary pharmacology & therapeutics Vol. 21; no. 5; pp. 583 - 590
• Main Authors: Kotowska, M., Albrecht, P., Szajewska, H.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Science Ltd 01.03.2005; Blackwell
• Subjects: Adolescent; Anti-Bacterial Agents - adverse effects; Biological and medical sciences; Child; Child, Preschool; Diarrhea - chemically induced; Diarrhea - prevention & control; Digestive system; Double-Blind Method; Female; Gastroenterology. Liver. Pancreas. Abdomen; Humans; Infant; Male; Medical sciences; Pharmacology. Drug treatments; Probiotics - therapeutic use; Saccharomyces; Treatment Outcome; Human; Diarrhea; Saccharomyces; Fungi; Prevention; Antibiotic; Randomization; Double blind study; Digestive diseases; Intestinal disease; Ascomycetes; Child; Thallophyta
• ISSN: 0269-2813; 1365-2036
• DOI: 10.1111/j.1365-2036.2005.02356.x

Summary 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 (≥3 loose or watery stools/day for ≥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.