Traditional Dietary Advice Vs. Mediterranean Diet in IBS

Irritable Bowel Syndrome Clinical Trial

Official title:

A Randomized Trial of Traditional Dietary Advice Versus Mediterranean Diet in Irritable Bowel Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05985018
• Other study ID #: STH20655b
• Status: Recruiting
• Phase: N/A
• Start date: September 30, 2023
• Est. completion date: May 31, 2026

Study information

• Verified date: April 2024
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: Jemima Clarke
• Phone: 01142265943
• Email: sth.researchadministration[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Irritable bowel syndrome (IBS) affects 5-10% of the population, and incurs substantial health impairment and healthcare utilization. Over 80% of individuals with IBS report food to trigger or aggravate symptoms, with many seeking to undertake dietary modifications. Current guidelines recommend first-line therapy with the relatively straightforward traditional dietary advice, with the more complex and restrictive low FODMAP diet reserved as second-line therapy. There is emerging data suggesting that the Mediterranean diet may also improve the symptoms of IBS, although it has not yet been subject to any head-to-head randomized dietary trials to help position it within the treatment algorithm. Given the relative ease of implementing the Mediterranean diet, alongside its recognized cardio-metabolic and mental health benefits, studying its efficacy in IBS is attractive as it could potentially pave the way for another first-line dietary option being available to patients before escalating to the demanding and resource intensive second-line therapies. The investigators will perform a randomized trial comparing the clinical efficacy of traditional dietary advice vs. a Mediterranean diet in IBS. Following dietary randomization, participants will complete validated questionnaires to assess changes in IBS symptoms, quality of life, mood, somatic symptoms, nutritional status, as well as dietary satisfaction and adherence.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 134
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• IBS Symptom Severity Scale(IBS-SSS) > 75
• Online access
• English literate

Exclusion Criteria:

• Organic gastrointestinal diseases (e.g. inflammatory bowel disease, GI cancer, coeliac disease, microscopic colitis, bile acid diarrhoea)
• Major abdominal surgery (except laparoscopy, appendectomy, cholecystectomy)
• History of eating disorder
• Body mass index <20
• Current dietary interventions
• Current use of opioids/antibiotics
• Titrating dose of neuromodulators
• Severe systemic disease (e.g. cardiac, renal, respiratory, psychiatric) necessitating frequent medical consultations/hospitilisations
• Pregnant
• Diabetes mellitus
• Scleroderma
• Memory impairment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Other:
• Traditional Diet
Provided as an educational leaflet
• Mediterranean Diet
Provided as an educational leaflet

Locations

Country	Name	City	State
United Kingdom	Royal Hallamshire Hospital	Sheffield	South Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of IBS patients experiencing clinical response with traditional dietary advice vs. Mediterranean diet	IBS symptom severity scale (IBS-SSS) where a 50-point reduction denotes a meaningful clinical response	Baseline to Week 6
Secondary	Changes in individual items of the IBS-SSS	IBS- SSS contains 5 specific questions (pain severity, pain frequency, abdominal distension severity, bowel movement satisfaction, quality of life) with score ranging from 0-100. Change in individual items will be compared within- and between- groups.	Baseline to Week 6
Secondary	Changes in Anxiety and Depression	The four-item patient health questionnaire (PHQ-4) for anxiety and depression is a validated questionnaire assessing mood, with higher scores representing worse mood. Change in scores will be compared within- and between- groups	Baseline to Week 6
Secondary	Changes in Somatic Symptom reporting	The validated patient health questionnaire-12 assess extra-intestinal somatic symptoms, with higher scores representing greater somatic symptom severity. Change in scores will be compared within- and between- groups	Baseline to Week 6
Secondary	Changes in quality of life	The validated Short form 8 Quality of life Questionnaire assesses quality of life, with higher scores representing better quality of life. Change in scores will be compared within- and between- groups	Baseline to Week 6
Secondary	Dietary satisfaction to assigned intervention	The Diet Satisfaction Score is a 10-item questionnaire assessing dietary satisfaction to an allocated diet (either Mediterranean diet or traditional diet), with higher scores representing greater satisfaction. Changes in score will be compared between the groups.	Week 6
Secondary	Adherence to the Mediterranean diet	The 14-point Mediterranean Diet Adherence Screener will check adequate dietary adherence, which we expect will be seen in those assigned a Mediterranean diet compared with traditional diet. Higher scores represent better adherence.	Week 6
Secondary	Changes in nutritional intake	The Comprehensive Nutritional Assessment Questionnaire assesses macronutrient and micronutrient intake, FODMAPs, fibre, starch, glycaemic index/load. Change in scores will be compared within- and between- groups. Only a subset will complete this	Baseline to Week 6