Mourey F, Decherf A, Jeanne JF, Clément-Ziza M, Grisoni ML, Machuron F, Legrain-Raspaud S, Bourreille A, Desreumaux P. Saccharomyces cerevisiae I-3856 in irritable bowel syndrome with predominant constipation. World J Gastroenterol 2022; 28(22): 2509-2522 [PMID: 35979259 DOI: 10.3748/wjg.v28.i22.2509]
Corresponding Author of This Article
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
Research Domain of This Article
Gastroenterology & Hepatology
Article-Type of This Article
Randomized Controlled Trial
Open-Access Policy of This Article
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/
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
Abstract
BACKGROUND
Probiotics are a promising solution for managing irritable bowel syndrome (IBS). Saccharomyces cerevisiae (S. cerevisiae) I-3856 has already demonstrated beneficial effects in IBS subjects, particularly in IBS with predominant constipation (IBS-C).
AIM
To confirm the efficacy of S. cerevisiae I-3856 in the management of gastrointestinal symptoms in IBS-C.
METHODS
A randomized, double-blind, placebo-controlled clinical study was performed in a total of 456 subjects. After a run-in period, subjects were randomly assigned to the group receiving S. cerevisiae I-3856 (8 × 109 CFU daily) or the placebo for 8 wk, and they 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).
RESULTS
A significantly higher proportion of abdominal pain responders was reported in the Probiotic group (45.1% vs 33.9%, P = 0.017). A nonsignificant difference in the area under the curve for abdominal pain over the second month of supplementation was observed in subjects receiving probiotic vs placebo [P = 0.073, 95%CI: -0.59 (-1.23; 0.05)]. No statistically significant differences were reported in the evolution of bowel movement frequency and stool consistency between the groups. After 8 wk of supplementation, the overall QOL score was significantly higher in the Probiotic group than in the Placebo group [P = 0.047, 95%CI: 3.86 (0.52; 7.20)]. Furthermore, exploratory analyses showed statistically significant and clinically relevant improvements in QOL scores in abdominal pain responders vs nonresponders.
CONCLUSION
The results of this clinical study confirmed the abdominal pain alleviation properties of S. cerevisiae I-3856 in IBS-C. Abdominal pain relief was associated with improved QOL. ClinicalTrials.gov identifier: NCT03150212.
Core Tip: The gut microbiota has been proposed as central in irritable bowel syndrome (IBS) pathophysiology, and microbiota-directed intervention has therefore drawn considerable interest. Probiotics have been recognized as a potential solution for acting on the multifactorial causes and clinical symptoms of IBS. Among them, Saccharomyces cerevisiae (S. cerevisiae) CNCM I-3856 is a probiotic yeast that has shown beneficial effects on gastrointestinal symptoms of individuals with IBS, especially in IBS subjects with predominant constipation. This clinical study confirmed the abdominal pain alleviation properties of S. cerevisiae I-3856 in IBS with predominant constipation and showed improvements in quality of life in the group receiving the probiotic.
