Assessing 'response' to the low-FODMAP diet in irritable bowel syndrome: Should we be reporting harder primary endpoints?

Conley, Thomas Edward ORCID: 0000-0002-0604-0770, Parkes, Miles, Moss, Stephen and Probert, Chris ORCID: 0000-0003-0477-6714
(2024) Assessing 'response' to the low-FODMAP diet in irritable bowel syndrome: Should we be reporting harder primary endpoints? Clinical nutrition (Edinburgh, Scotland), 43 (5). pp. 1079-1086.

Access the full-text of this item by clicking on the Open Access link.


<h4>Background & aims</h4>The low-FODMAP diet (LFD) has become almost synonymous with IBS care, yet the challenges associated with this rigorous therapeutic approach are often underacknowledged. Despite positive outcomes in RCTs, comparator groups frequently exhibit substantial response rates, raising questions about the definition of 'response'. Whilst the assessment of response in drug trials has evolved to utilize the more stringent FDA/EMA primary clinical endpoints, trials of the LFD have not yet followed. The aim of this article is to opine whether the current approach to the measurement of clinical response to the LFD in clinical trials should be reconsidered.<h4>Methods</h4>A comprehensive literature review of LFD clinical trials from the past decade was conducted, focusing on recorded response metrics for primary clinical endpoints.<h4>Results</h4>While response definitions vary, the 50-point IBS-SSS delta emerged as the predominant metric. Notably, no trials to date have adopted the more stringent primary clinical endpoints used in drug trials. Other response measures included binary response metrics (such as 'adequate clinical response'), changes in visual analogue scales or stool form/output, reductions in abdominal pain, as well as changes the magnitude of the IBS-SSS delta. Whether these metrics correspond to a clinically meaningful improvement for the patient is less clear, and as such aligning patient-clinician expectations can be challenging.<h4>Conclusions</h4>A paradigm shift in the conceptualization of 'response' coupled with an emphasis on harder clinical endpoints in the context of clinical trials may serve to better justify the trade-off between symptom-improvement and the inherent challenges associated with this burdensome therapeutic approach.

Item Type: Article
Uncontrolled Keywords: Humans, Irritable Bowel Syndrome, Treatment Outcome, Endpoint Determination, Diet, Carbohydrate-Restricted, Randomized Controlled Trials as Topic, FODMAP Diet
Divisions: Faculty of Health and Life Sciences
Faculty of Health and Life Sciences > Institute of Systems, Molecular and Integrative Biology
Depositing User: Symplectic Admin
Date Deposited: 17 Apr 2024 10:42
Last Modified: 11 May 2024 02:34
DOI: 10.1016/j.clnu.2024.03.017
Open Access URL:
Related URLs: