Clinical trial: effectiveness of Lactobacillus rhamnosus (strains E/N, Oxy and Pen) in the prevention of antibiotic‐associated diarrhoea in children

Summary Background Convincing evidence that probiotic administration can lower the risk of antibiotic‐associated diarrhoea is limited to certain micro‐organisms. Aim To determine the efficacy of administration of Lactobacillus rhamnosus (strains E/N , Oxy and Pen ) for the prevention of antibiotic‐associated diarrhoea in children. Methods Children (aged 3 months to 14 years) with common infections were enrolled in a double‐blind, randomized, placebo‐controlled trial in which they received standard antibiotic treatment plus 2 × 10 10 colony forming units of a probiotic ( n = 120) or a placebo ( n = 120), administered orally twice daily throughout antibiotic treatment. Analyses were by intention to treat. Results Any diarrhoea (≥3 loose or watery stools/day for ≥48 h occurring during or up to 2 weeks after the antibiotic therapy) occurred in nine (7.5%) patients in the probiotic group and in 20 (17%) patients in the placebo group (relative risk, RR 0.45, 95% confidence interval, CI 0.2–0.9). Three (2.5%) children in the probiotic group developed AAD (diarrhoea caused by Clostridium difficile or otherwise unexplained diarrhoea) compared to nine (7.5%) in the placebo group (RR 0.33, 95% CI 0.1–1.06). No adverse events were observed. Conclusion Administration of L. rhamnosus (strains E/N , Oxy and Pen ) to children receiving antibiotics reduced the risk of any diarrhoea, as defined in this study.