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Saccharomyces boulardii in the prevention of antibiotic‐associated diarrhoea in children: a randomized double‐blind placebo‐controlled trial
Author(s) -
Kotowska M.,
Albrecht P.,
Szajewska H.
Publication year - 2005
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/j.1365-2036.2005.02356.x
Subject(s) - saccharomyces boulardii , medicine , placebo , antibiotic associated diarrhea , randomized controlled trial , antibiotics , relative risk , confidence interval , adverse effect , respiratory tract infections , diarrhea , clostridium difficile , gastroenterology , probiotic , respiratory system , microbiology and biotechnology , alternative medicine , pathology , genetics , bacteria , biology
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.