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

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

Author information

1
McGill University, Department of Biomedical Engineering, Faculty of Medicine, Biomedical Technology and Cell Therapy Research Laboratory , 3775 University Street, Montreal, Quebec, H3A2B4 , Canada +1 514 398 3676; +1 514 398 7461; satya.prakash@mcgill.ca.

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.

PMID:
24074303
DOI:
10.1517/14712598.2013.833601
[Indexed for MEDLINE]

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