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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.

Research Insights

SupplementHealth OutcomeEffect TypeEffect Size
Lactobacillus reuteri NCIMB 30242Improved Diarrhea SymptomsBeneficial
Moderate
Lactobacillus reuteri NCIMB 30242Improved Gastrointestinal HealthBeneficial
Moderate
Lactobacillus reuteri NCIMB 30242Reduced Diarrhea SymptomsBeneficial
Moderate
LRC (NCIMB 30242)Improved General GI Health StatusBeneficial
Moderate
LRC (NCIMB 30242)Improved Overall Gastrointestinal HealthBeneficial
Moderate
LRC (NCIMB 30242)Reduced Diarrhea SymptomsBeneficial
Moderate

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