Lactobacillus reuteri DSM 17938 in the prevention of antibiotic-associated diarrhoea in children: a randomized clinical trial

Abstract

Objectives: To assess the effectiveness of Lactobacillus reuteri DSM 17938 for the prevention of diarrhoea and antibiotic-associated diarrhoea (AAD) in children.

Methods: Hospitalized children who received antibiotics were assigned by a computer-generated list to receive L. reuteri (at 2 × 10⁸ CFU) or placebo, twice daily, for the duration of antibiotic treatment. Follow up was for 1 week after antibiotic cessation. The primary outcome measures were diarrhoea and AAD. Both were defined according to one of three definitions (i) three or more loose or watery stools per day for ≥48 h; (ii) three or more loose or watery stools per day for ≥24 h; or (iii) two or more loose or watery stools per day for ≥24 h. For AAD, it had to be diarrhoea caused by Clostridium difficile or otherwise unexplained diarrhoea.

Results: A total of 250 children were randomized and 247 were analysed (L. reuteri n = 123, placebo n = 124; median age 4 months). The occurrences of diarrhoea and AAD were similar in both groups, regardless of the definition used. Using the strictest definition (i.e. definition (i)), the occurrence of diarrhoea in the L. reuteri group was 25 (20%) compared with 16 (13%) in the placebo group (absolute risk reduction -0.07 (-0.17 to 0.02). The occurrence of AAD was 14 (11.4%) in the L. reuteri group compared with 8 (6.5%) in the placebo group (absolute risk reduction -0.05 (-0.13 to 0.02)). The groups were similar with respect to all secondary outcome measures, including adverse events.

Conclusions: Lactobacillus reuteri was not effective in the prevention of diarrhoea or AAD in children.

Keywords: Antibiotic; Children; Diarrhea; Lactobacillus reuteri; Randomized clinical trial.