Randomised clinical trial: Lactobacillus reuteri DSM 17938 vs. placebo in children with acute diarrhoea--a double-blind study

Aliment Pharmacol Ther. 2012 Aug;36(4):363-9. doi: 10.1111/j.1365-2036.2012.05180.x. Epub 2012 Jun 11.


Background: Probiotics may be of help for the management of acute diarrhoea, however, the effect is strain specific and efficacy needs to be proven.

Aim: To test the efficacy and safety of Lactobacillus reuteri DSM 17938 derived from L. reuteri ATCC 55730 in children with acute diarrhoea. Primary outcomes were the rate of unresolved diarrhoea after 3 days of treatment and duration of diarrhoea.

Methods: Children (6-36 months), hospitalised in three paediatric hospitals in Southern Italy for acute diarrhoea with clinical signs of dehydration were randomised to receive in a double-blind fashion either L. reuteri (dose of 4 × 10(8) colony-forming units/die) or placebo.

Results: Out of 96 eligible children, 74 were enrolled, five patients were withdrawn; 35 in the L. reuteri group and 34 in the placebo group. Lactobacillus reuteri significantly reduced the duration of watery diarrhoea as compared with placebo (2.1 ± 1.7 days vs. 3.3 ± 2.1 days; P < 0.03); on day two and three of treatment watery diarrhoea persisted in 82% and 74% of the placebo and 55% and 45% of the L. reuteri recipients respectively (P < 0.01; P < 0.03). Finally, children receiving L. reuteri had a significantly lower relapse rate of diarrhoea (15% vs. 42%; P < 0.03). There was not a significant difference in hospital stay between the groups. No adverse events were recorded.

Conclusion: Our study shows that L . reuteri DSM 17938 as an adjunct to rehydration therapy is efficacious in the treatment of acute diarrhoea reducing the frequency, duration and recrudescence rate of the disease.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Child, Preschool
  • Dehydration / physiopathology
  • Dehydration / therapy*
  • Diarrhea / physiopathology
  • Diarrhea / therapy*
  • Double-Blind Method
  • Female
  • Fluid Therapy
  • Gastroenteritis / physiopathology
  • Gastroenteritis / therapy*
  • Hospitalization
  • Humans
  • Infant
  • Italy
  • Lactobacillus reuteri / physiology*
  • Male
  • Probiotics / therapeutic use*
  • Recurrence
  • Treatment Outcome