A randomized, double-blind, placebo-controlled pilot study of Lactobacillus reuteri ATCC 55730 for the prevention of antibiotic-associated diarrhea in hospitalized adults

J Clin Gastroenterol. 2011 Oct;45(9):785-9. doi: 10.1097/MCG.0b013e3182166a42.


Goals: The purpose of the study was to evaluate Lactobacillus reuteri for the prevention of antibiotic-associated diarrhea (AAD) in hospitalized adults.

Background: AAD is a problem in hospitalized adults, contributing to increased length of stay, cost, and mortality. Probiotics have been proposed as a way to prevent AAD. L. reuteri decreases acute infectious diarrhea in children; however, L. reuteri has never been evaluated for the prevention of AAD.

Study: In a randomized, double-blind, placebo-controlled pilot study, in-patients receiving antibiotics were given L. reuteri 1×10 colony-forming units twice daily or an identical placebo for 4 weeks. Stool frequency, consistency, and gastrointestinal symptoms were monitored during the 4-week treatment period and during a 2-week follow-up period.

Results: A total of 31 patients were enrolled. Eight patients were excluded in the data analysis because of length of study participation less than 14 days. Mean age was 51 ± 18 years; 63% were female and 37% male. Most frequent primary diagnosis was pneumonia (20%), followed by abscess (10%), chronic obstructive pulmonary disease (6.7%), and bronchitis (6.7%). Thirteen patients received L. reuteri and 10 received placebo. Patients treated with L. reuteri had a significantly lower frequency of diarrhea compared with placebo (50% in the placebo group vs. 7.7% in the probiotic group, P=0.02). There were no differences in the frequency or severity of gastrointestinal symptoms.

Conclusions: In this placebo-controlled, pilot study, L. reuteri twice daily for 4 weeks significantly decreased AAD among hospitalized adults. L. reuteri was safe and well tolerated.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Anti-Bacterial Agents / adverse effects*
  • Anti-Bacterial Agents / therapeutic use
  • Colony Count, Microbial
  • Diarrhea / chemically induced
  • Diarrhea / prevention & control*
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Hospitals
  • Humans
  • Length of Stay
  • Limosilactobacillus reuteri*
  • Male
  • Middle Aged
  • Pilot Projects
  • Severity of Illness Index


  • Anti-Bacterial Agents