Improvement of gastrointestinal health status in subjects consuming Lactobacillus reuteri NCIMB 30242 capsules: a post-hoc analysis of a randomized controlled trial

Expert Opin Biol Ther. 2013 Dec;13(12):1643-51. doi: 10.1517/14712598.2013.833601. Epub 2013 Sep 28.

Abstract

Objective: Gastrointestinal (GI) symptoms are conditions that are frequently observed in clinical practice. A post-hoc analysis has been undertaken to evaluate the effect of bile salt hydrolase-active L. reuteri NCIMB 30242 on GI health status based on Rome III questionnaire response in otherwise healthy hypercholesterolemic subjects.

Research design/methods: A total of 127 subjects received either L. reuteri NCIMB 30242 or placebo capsules over a 9-week intervention in a randomized, double-blind, placebo-controlled, parallel-arm, multicenter study. Subjects were asked to complete the Rome III diagnostic GI questionnaire prior to the baseline and end point visits of the clinical study.

Main outcome measure: GI health status was evaluated, per questionnaire, by assessing all questions with 5- or 7-point response scales for symptoms of the stomach and intestines.

Results: Subjects receiving L. reuteri NCIMB 30242 reported significant improvements in general GI health status (p = 0.029) and in symptoms related to diarrhea (p = 0.018) as compared to placebo over the intervention period. Further, a greater proportion of L. reuteri-treated subjects showed improved general GI health status (p = 0.042) and improved diarrhea symptoms (p = 0.03).

Conclusions: L. reuteri NCIMB 30242 capsules appear to be well tolerated and potentially beneficial for GI health status. Further clinical investigation is warranted for the treatment of functional GI disorders.

Trial registration: ClinicalTrials.gov NCT01341613.

Publication types

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

MeSH terms

  • Capsules
  • Double-Blind Method
  • Female
  • Gastrointestinal Diseases / diagnosis
  • Gastrointestinal Diseases / etiology
  • Gastrointestinal Diseases / therapy*
  • Health Status*
  • Humans
  • Lactobacillus reuteri*
  • Male
  • Middle Aged
  • Probiotics / administration & dosage*
  • Prognosis
  • Surveys and Questionnaires

Substances

  • Capsules

Associated data

  • ClinicalTrials.gov/NCT01341613