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

Bifidobacterium longum 35624 has shown efficacy in improving irritable bowel syndrome (IBS) symptoms compared with placebo in double-blind randomized studies. However, few data are available from real-life clinical practice or from studies that used Rome IV criteria to diagnose IBS.


To assess the effect of B. longum 35624 on IBS severity and quality of life in a real-life setting.


From November 2018 to January 2020, 278 patients with IBS (according to Rome IV criteria) were enrolled in a prospective, open-label, multicenter observational study by private practice gastroenterologists to received one capsule of B. longum 35624 (109 colony-forming units) per day for 30 d. Participation in the study was independently proposed to patients during spontaneous consultations. Disease severity (assessed by the IBS severity scoring system) and patient quality of life (assessed by the IBS quality of life questionnaire) were compared between the inclusion visit (baseline) and the visit at the end of 30 d of treatment. The characteristics of patients were described at baseline. Continuous variables comparisons between inclusion and end-of-treatment visits were performed using the t-test and Kruskal-Wallis test. Categorical variables comparisons were performed using the χ2 test.


A total of 233 patients, with a mean age of 51.4 years and composed of 71.2% women, were included in the study. Of these patients, 48.1% had moderate IBS and 46.4% had severe IBS. After a 30-d treatment period with one B. longum 35624 capsule per day, a significant decrease in IBS severity was observed compared to baseline (mean ± SD, IBS severity scoring system scores: 208 ± 104 vs 303 ± 81, P < 0.001) and 57% of patients moved to lower severity categories or achieved remission. The quality of life of patients was also improved by the treatment (IBS Quality of Life questionnaire score: 68.8 ± 20.9 vs 60.2 ± 20.5; P < 0.001) and 63.8% of patients were satisfied with the treatment.


Thirty days of treatment with B. longum 35624 reduces disease severity and improves the quality of life of patients with IBS, particularly those with the most severe forms of IBS.

Keywords: Irritable bowel syndrome, Probiotics, Bifidobacterium longum, Quality of life, Severity of illness index, Abdominal pain

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.