Bamidele, J.O., Brownlow, G.M., Flack, R.M. et al. (4 more authors) (2025) The Mediterranean diet for irritable bowel syndrome. Annals of Internal Medicine. ISSN: 0003-4819
Abstract
Background:
Patients with irritable bowel syndrome (IBS) frequently seek dietary advice, but few evidence-based options exist. Major societal guidelines recommend traditional dietary advice (TDA) as first-line therapy, with the cumbersome and resource-intensive low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP) diet reserved as second-line therapy. Recent pilot data suggest that the Mediterranean diet (MD), renowned for its general health benefits, improves IBS symptoms, but whether it can be considered another first-line dietary option is unknown.
Objective:
To determine if the MD is noninferior to TDA in managing IBS symptoms.
Design:
Randomized noninferiority clinical trial. (ClinicalTrials.gov: NCT05985018)
Setting:
Online virtual platform.
Participants:
139 persons with IBS from across the United Kingdom.
Intervention:
6 weeks of the MD (n = 68) or TDA (n = 71).
Measurements:
Primary end point was the proportion achieving clinical response, defined as 50-point or greater reduction in IBS Symptom Severity Scale (IBS-SSS). Secondary outcomes included changes in IBS-SSS scores, psychological health, somatic symptom reporting, quality of life, diet satisfaction, and Mediterranean Diet Adherence Screener (MEDAS). Results: Baseline characteristics (mean age, 40.4 years [range, 19 to 65 years]; 80% women) and IBS-SSS (mean, 309 [SD, 90]) were similar between groups. On modified intention-to-treat analysis, the primary end point was met by 62% (95% CI, 50% to 73%) following a MD versus 42% (CI, 31% to 55%) following TDA. The difference in clinical response favored the MD (difference, 20 percentage points [CI, 4 to 36 percentage points]; P = 0.017), demonstrating noninferiority and superiority. There was a greater reduction in the mean IBS-SSS after a MD than TDA (−101.2 vs. −64.5; Δ−36.7 [CI,−70.5 to −2.8]; P = 0.034). No statistically significant differences were seen between the groups with regard to changes in mood, somatic symptoms, quality of life, or diet satisfaction. The MEDAS significantly increased after a MD compared with TDA (P < 0.001).
Limitation:
No long-term data.
Conclusion:
The MD showed noninferiority and superiority to TDA in managing IBS symptoms. It represents a viable first-line dietary intervention for IBS.
Primary Funding Source:
None
Metadata
| Item Type: | Article |
|---|---|
| Authors/Creators: |
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| Copyright, Publisher and Additional Information: | © 2025 American College of Physicians. |
| Keywords: | Abdominal pain; Diet; Eating; Irritable bowel syndrome; Nutrition; Quality of life; Questionnaires; Randomized trials; Signs and symptoms; Statistical data; Treatment guidelines |
| Dates: |
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| Institution: | The University of Sheffield |
| Academic Units: | The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > School of Medicine and Population Health The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > Department of Infection, Immunity and Cardiovascular Disease |
| Date Deposited: | 02 Dec 2025 14:59 |
| Last Modified: | 02 Dec 2025 14:59 |
| Status: | Published online |
| Publisher: | American College of Physicians |
| Refereed: | Yes |
| Identification Number: | 10.7326/annals-25-01519 |
| Related URLs: | |
| Sustainable Development Goals: | |
| Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:235036 |
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Filename: RCT IBS MD_FINAL.pdf


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