Traditional Dietary Advice Vs. Mediterranean Diet in IBS

NHS Foundation Trust

Status: Completed

Conditions: Irritable Bowel Syndrome

Treatments: Other: Mediterranean Diet; Other: Traditional Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05985018

STH20655b

Details and patient eligibility

About

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.

Enrollment: 139 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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139 participants in 2 patient groups

Traditional Dietary Advice

Active Comparator group

Description:

Its main elements are to adopt sensible eating habits and avoid excess fatty foods, spicy foods, processed foods, caffeine, fizzy drinks and alcohol.

Treatment:

Other: Traditional Diet

Mediterranean Diet

Active Comparator group

Description:

The principle components is a diet rich in vegetables, pulses, whole grains, and olive oil

Treatment:

Other: Mediterranean Diet