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


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.


METHODS
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.
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.
Mitchell L
ML
Jones
Christopher J
CJ
Martoni
Jorge G
JG
Ganopolsky
Imran
I
Sulemankhil
Peter
P
Ghali
Satya
S
Prakash
D002214:Capsules; D004311:Double-Blind Method; D005260:Female; D005767:Gastrointestinal Diseases / Q000175:diagnosis / Q000209:etiology / Q000628:therapy*; D006304:Health Status; D006801:Humans; D052200:Limosilactobacillus reuteri; D008297:Male; D008875:Middle Aged; D019936:Probiotics / Q000008:administration & dosage*; D011379:Prognosis; D011795:Surveys and Questionnaires
D002214:Capsules