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
Abstract
BACKGROUND

Irritable bowel syndrome (IBS) symptoms are common in patients with inflammatory bowel disease (IBD), with systematic review reporting an overall pooled prevalence of 35-39% in patients with clinical remission. This subset of patients reports a reduced quality of life and increased anxiety and depression. A multi-strain probiotic (Symprove™, Symprove Ltd, Farnham, United Kingdom) has been shown to improve overall symptom severity in patients with IBS and is associated with decreased intestinal inflammation in patients with ulcerative colitis (UC), but not in Crohn’s disease (CD).

AIM

To ascertain whether this multi-strain probiotic would be effective in an IBS/IBD overlap population.

METHODS

The treatment of symptoms in the absence of inflammation in inflammatory bowel diseases trial was a randomized, double-blind, placebo-controlled trial of a four-strain probiotic Symprove, containing Lactobacillus rhamnosus NCIMB 30174, Lactobacillus plantarum NCIMB 30173, Lactobacillus acidophilus NCIMB 30175 and Enterococcus faecium NCIMB 30176. The duration of the study was 3 months, at the end of which IBS-Symptom Severity Score (IBS-SSS) was repeated. Primary Endpoint was a 100-point reduction in IBS-SSS.

RESULTS

61 participants were randomized into the intention-to-treat analysis. 45% of patients receiving the active agent achieved the endpoint compared to 33% of those receiving placebo (P = 0.42). In UC, 50% of patients receiving placebo achieved the endpoint compared to 44% of those receiving the active agent (P = 1.00). In CD 45% of those receiving the active agent achieved the endpoint compared to 29% of those receiving placebo (P = 0.34). The mean change in IBS-SSS for patients receiving placebo was a reduction of 61 points, compared to a reduction in 90 points for patients receiving active agent (P = 0.31). There was no difference between the groups with regard to IBD outcomes.

CONCLUSION

Probiotics may represent a safe and effective means of addressing the unmet clinical need for symptom relief in patients with overlapping IBS and IBD, especially in those with CD.

Keywords: Irritable bowel syndrome; Inflammatory bowel disease; Crohn's disease; Ulcerative colitis; Probiotics

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.