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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.
Acknowledgments
The clinical trial was registered in a public registry (clinicaltrials.gov; study number NCT01341613). The authors kindly thank J. Lahovský, V. Voštiňáková, M. Svobodová, and K. Beber for their contribution to the study. They also thank all volunteers who participated in the study. M.L.J, C.J.M, and S.P. designed the study; M.L.J, C.J.M, J.G.G, P.G. and S.P. prepared the manuscript; J.L, V.V and M.S. conducted the research; K.B, I.S, J.G.G. and C.J.M. prepared the data and performed the statistical analysis.
Declarations of interest
This work was supported by Micropharma Ltd. S. Prakash and M.L. Jones acknowledge a conflict of interest as they are co-founders and shareholders of Micropharma. C.J. Martoni. and J.G. Ganopolsky are employed by Micropharma and C. J. Martoni is a shareholder of Micropharma. All other authors declare no conflict of interest. All authors have read and approved the final manuscript.