Clinical Trials Study
Copyright ©The Author(s) 2016. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Dec 28, 2016; 22(48): 10631-10642
Published online Dec 28, 2016. doi: 10.3748/wjg.v22.i48.10631
Irritable bowel syndrome symptom severity improves equally with probiotic and placebo
Anna Lyra, Markku Hillilä, Teppo Huttunen, Sofia Männikkö, Mikko Taalikka, Julia Tennilä, Anneli Tarpila, Sampo Lahtinen, Arthur C Ouwehand, Lea Veijola
Anna Lyra, Julia Tennilä, Anneli Tarpila, Sampo Lahtinen, Arthur C Ouwehand, DuPont Nutrition and Health, Global Health and Nutrition Science, Danisco Sweeteners Oy, 02460 Kantvik, Finland
Markku Hillilä, Clinic of Gastroenterology, University of Helsinki and University Hospital, 00290 Helsinki, Finland
Teppo Huttunen, Sofia Männikkö, Mikko Taalikka, 4Pharma Ltd, Lemminkäisenkatu 1, 20520 Turku, Finland
Lea Veijola, Mehiläinen Oy, Pohjoinen Hesperiankatu 17, 00260 Helsinki, Finland
Author contributions: Lyra A, Hillilä M, Huttunen T, Männikkö S, Taalikka M, Tennilä J, Tarpila A, Lahtinen S, Ouwehand AC and Veijola L designed the study; Veijola L was the principal investigator and Hillilä M was the co-investigator; Lyra A and Ouwehand AC managed the trial; Huttunen T and Männikkö S were responsible for the statistics; Taalikka M performed the data management; Tennilä J and Tarpila A monitored the trial; Lyra A, Hillilä M, Huttunen T, Männikkö S, Taalikka M, Tennilä J, Ouwehand AC, and Veijola L wrote the manuscript; all authors have read and approved the manuscript.
Institutional review board statement: This study was reviewed and approved by the Hospital District of Helsinki and Uusimaa (HUS) Ethics Committee of Medicine (initial ethical approval 251/13/03/01/2012 dated 15.8.2012, received 17.8.2012).
Clinical trial registration statement: This study has been registered at Clinicaltrials.gov. The registration identification number is NCT01728610. The study was registered before study recruitment commenced.
Informed consent statement: All volunteers provided written informed consent before any study-specific procedures or assessments were performed.
Conflict-of-interest statement: Anna Lyra, Julia Tennilä, Anneli Tarpila, Sampo Lahtinen, and Arthur C Ouwehand are present or former employees of the sponsor, DuPont Nutrition and Health.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Anna Lyra, PhD, Senior Scientist, DuPont Nutrition and Health, Global Health and Nutrition Science, Danisco Sweeteners Oy, Sokeritehtaantie 20, 02460 Kantvik, Finland. anna.lyra@dupont.com
Telephone: +358-40-8241732 Fax: +358-10-4315555
Received: April 13, 2016
Peer-review started: April 14, 2016
First decision: June 20, 2016
Revised: July 13, 2016
Accepted: July 31, 2016
Article in press: August 1, 2016
Published online: December 28, 2016
Processing time: 256 Days and 22.1 Hours
Core Tip

Core tip: Symptoms of irritable bowel syndrome (IBS) might benefit from probiotic interventions, although mechanistic insights into probiotic function are seldom available. Lactobacillus acidophilus NCFM induces human colonic mucosal opioid receptor expression - the putative mechanism by which visceral pain is alleviated. In this study, 391 volunteers with IBS were treated with 109 or 1010 colony-forming units of NCFM or placebo and evaluated using symptom questionnaires. NCFM was not superior to placebo in improving the composite IBS symptom score, whereas abdominal pain - as an individual symptom - declined in IBS volunteers with moderate to severe pain at baseline.