Clinical Trials Study
Copyright ©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Pharmacol Ther. Jun 5, 2025; 16(2): 101268
Published online Jun 5, 2025. doi: 10.4292/wjgpt.v16.i2.101268
Four-strain probiotic exerts a positive effect on irritable bowel syndrome symptoms occurring in inflammatory bowel diseases in absence of inflammation (train-IBD trial)
Anne Fennessy, Micheal Doyle, Anna Boland, Rachel Bourke, Anthony O'Connor
Anne Fennessy, Micheal Doyle, Anna Boland, Rachel Bourke, Anthony O'Connor, Department of Gastroenterology, Tallaght University Hospital, Dublin D24NR0A, Ireland
Author contributions: Fennessy A and O’Connor A designed the research study; Fennessy A, Doyle M, Boland A, Bourke R performed the research including recruitment and clinical assessment; Fennessy A and O’Connor A prepared the manuscript.
Institutional review board statement: The study was reviewed and approved by the SJH/TUH Joint Research Ethics Committee Institutional Review Board. Reference Number 2018/09/26.
Clinical trial registration statement: The registration identification number is 2018-003419-23.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: The authors have no conflicts of interest to declare.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
Data sharing statement: Technical appendix, statistical code, and dataset available from the corresponding author at oconna12@tcd.ie.
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: Anthony O'Connor, MBChB, MD, MRCP, MSc, Associate Professor, Doctor, Senior Lecturer, Department of Gastroenterology, Tallaght University Hospital, Belgard Rd, Dublin D24NR0A, Ireland. oconna12@tcd.ie
Received: September 9, 2024
Revised: January 16, 2025
Accepted: April 25, 2025
Published online: June 5, 2025
Processing time: 266 Days and 21.9 Hours
Core Tip

Core Tip: A four-strain probiotic is well-tolerated in patients with inflammatory bowel disease (IBD) overlap and does not lead to adverse IBD related outcomes. Adequately powered studies are required to validate our observation of a trend towards better IBS outcomes in this group.