Randomized Controlled Trial
Copyright ©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Jun 14, 2022; 28(22): 2509-2522
Published online Jun 14, 2022. doi: 10.3748/wjg.v28.i22.2509
Saccharomyces cerevisiae I-3856 in irritable bowel syndrome with predominant constipation
Florian Mourey, Amélie Decherf, Jean-François Jeanne, Mathieu Clément-Ziza, Marie-Lise Grisoni, François Machuron, Sophie Legrain-Raspaud, Arnaud Bourreille, Pierre Desreumaux
Florian Mourey, Amélie Decherf, Jean-François Jeanne, Sophie Legrain-Raspaud, Research and Applications Department, Gnosis by Lesaffre, Lesaffre Group, Marcq-en-Baroeul 59700, France
Mathieu Clément-Ziza, Marie-Lise Grisoni, François Machuron, Data Science and Bioinformatics Laboratory, Research and Development Department, Lesaffre International, Lesaffre Group, Marcq-en-Baroeul 59700, France
Arnaud Bourreille, Institut des Maladies de l'Appareil Digestif, Centre Hospitalier Universitaire de Nantes, Nantes 44093, France
Pierre Desreumaux, Institute for Translational Research in Inflammation, Centre Hospitalier Universitaire de Lille, Lille 59000, France
Author contributions: Decherf A designed the study; Desreumaux P and Bourreille A contributed to the design of the study; Clément-Ziza M, Grisoni ML and Machuron F supervised the statistical analysis operations; Mourey F drafted the publication manuscript; Legrain-Raspaud S gave final approval of the version to be published; All authors participated in interpretation of the results, critically reviewed the manuscript and approved the final manuscript for submission.
Institutional review board statement: The study was reviewed and approved by the Ethics Committee Ouest VI of Brest, France.
Clinical trial registration statement: This study is registered at ClinicalTrials.gov. The registration identification number is NCT03150212.
Informed consent statement: All study participants provided informed written consent prior to study enrollment.
Conflict-of-interest statement: Mourey F, Decherf A, Jeanne JF, Clément-Ziza M, Machuron F and Legrain-Raspaud S are employees of Lesaffre. Grisoni ML was an employee of Lesaffre during her main contribution to the study. Bourreille A and Desreumaux P received financial support for research from Lesaffre.
Data sharing statement: No additional data are available.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (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: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Florian Mourey, MSc, Research Scientist, Research and Applications Department, Gnosis by Lesaffre, Lesaffre Group, 137 rue Gabriel Péri, Marcq-en-Baroeul 59700, France. f.mourey@gnosis.lesaffre.com
Received: December 22, 2021
Peer-review started: December 22, 2021
First decision: January 8, 2022
Revised: January 14, 2022
Accepted: April 28, 2022
Article in press: April 28, 2022
Published online: June 14, 2022
Processing time: 169 Days and 13.8 Hours
ARTICLE HIGHLIGHTS
Research background

The gut microbiota has been proposed as central in irritable bowel syndrome (IBS) pathophysiology, and microbiota-directed intervention has therefore drawn considerable interest. Among them, Saccharomyces cerevisiae (S. cerevisiae) CNCM I-3856 is a probiotic yeast that has emerged as a recognized solution for managing IBS.

Research motivation

S. cerevisiae I-3856 has demonstrated beneficial effects in IBS subjects, particularly in IBS with predominant constipation.

Research objectives

To confirm the efficacy of S. cerevisiae CNCM I-3856 on gastrointestinal symptom management in an IBS population with predominant constipation.

Research methods

A total of 456 subjects were enrolled in a randomized, double-blind, placebo-controlled trial. After a run-in period to confirm IBS diagnosis, subjects were randomly assigned to the group receiving the probiotic or the placebo for 8 wk and performed daily self-evaluations of gastrointestinal symptoms. The primary objective was to assess the effect of the probiotic on abdominal pain. The secondary objectives were the evaluation of other gastrointestinal symptoms, bowel movement frequency and consistency, and quality of life (QOL).

Research results

Abdominal pain alleviation during supplementation with S. cerevisiae CNCM I-3856 was confirmed by the higher proportion of abdominal pain responders in the probiotic group than in the placebo group. Importantly, this clinical study also showed improvements in QOL in the probiotic group.

Research conclusions

The results of this large-scale clinical study are consistent with previous findings and confirm the safety and efficacy of S. cerevisiae CNCM I-3856 for abdominal pain management in IBS population. In addition, abdominal pain alleviation was associated with significant improvements in IBS-related QOL.

Research perspectives

Dietary supplementation with S. cerevisiae CNCM I-3856 appears to be an interesting complementary or alternative solution for IBS management with positive implications for the day-to-day life of individuals with IBS with predominant constipation. Differences in microbiota composition and function between abdominal pain responders and nonresponders may provide a mechanistic basis for the beneficial effects of S. cerevisiae CNCM I-3856 in IBS management and warrant further exploration.