Observational Study
Copyright ©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Feb 21, 2022; 28(7): 732-744
Published online Feb 21, 2022. doi: 10.3748/wjg.v28.i7.732
Effect of Bifidobacterium longum 35624 on disease severity and quality of life in patients with irritable bowel syndrome
Jean-Marc Sabaté, Franck Iglicki
Jean-Marc Sabaté, Department of Gastroenterology, Hôpital Avicenne, AP-HP, Sorbonne Paris Nord, Bobigny 93000, France
Jean-Marc Sabaté, INSERM U-987, Pathophysiology and Clinical Pharmacology of Pain, Ambroise Paré Hospital, Boulogne-Billancourt 92100, France
Franck Iglicki, 15 allée Léon Gambetta, Clichy 92110, France
Author contributions: Sabaté JM and Iglicki F were responsible for conceptualization, methodology, writing—original draft preparation, and supervision of the study; Sabaté JM conducted the formal analysis and data curation; all authors have read and agreed to the published version of the manuscript.
Supported by Biocodex.
Institutional review board statement: The study was conducted according to the guidelines of the Declaration of Helsinki and the Guidelines for Good Clinical Practice (EMA/CHMP/ICH/135/1995), and approved by the Northwest III Protection of Persons Committee of the University Hospital of Caen (protocol code OBS 17-03; dated March 27, 2018 and approved on September 24, 2018).
Informed consent statement: An information sheet was provided to all patients, and oral non-opposition to the study was obtained from all patients involved in accordance with French regulation.
Conflict-of-interest statement: Sabaté JM and Iglicki F report personal fees from Biocodex during the conduct of the study. Sabaté JM also reports personal fees from Biocodex, Kyowa Kirin, Norgine, Mayoly Spindler, Arko Pharma, and Tillots Pharma outside the submitted work.
Data sharing statement: The data presented in this study are available on request from the corresponding author. The data are not publicly available due to privacy restrictions.
STROBE statement: The authors have read the STROBE Statement—checklist of items, and the manuscript was prepared and revised according to the STROBE Statement—checklist of items.
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: Jean-Marc Sabaté, MD, PhD, Full Professor, Department of Gastroenterology, Hôpital Avicenne, AP-HP, Sorbonne Paris Nord, 125 rue de Stalingrad, Bobigny 93000, France. jean-marc.sabate@aphp.fr
Received: September 7, 2021
Peer-review started: September 7, 2021
First decision: November 8, 2021
Revised: November 18, 2021
Accepted: January 19, 2022
Article in press: January 19, 2022
Published online: February 21, 2022
Processing time: 163 Days and 0.9 Hours
Core Tip

Core tip: Our observational study of 233 patients with moderate-to-severe irritable bowel syndrome demonstrated that 30 d of treatment with once-daily Bifidobacterium longum 35624 (a probiotic) resulted in a significant improvement in symptoms and disease severity for two thirds of the patients. Patient quality of life was also significantly improved, and the majority of patients expressed that they were satisfied with the treatment.