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Traditional Dietary Advice Vs. Mediterranean Diet in IBS - Trial NCT05985018

Access comprehensive clinical trial information for NCT05985018 through Pure Global AI's free database. This phase not specified trial is sponsored by Sheffield Teaching Hospitals NHS Foundation Trust and is currently Not yet recruiting. The study focuses on Irritable Bowel Syndrome. Target enrollment is 134 participants.

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NCT05985018
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Trial Details
ClinicalTrials.gov โ€ข NCT05985018
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Traditional Dietary Advice Vs. Mediterranean Diet in IBS
A Randomized Trial of Traditional Dietary Advice Versus Mediterranean Diet in Irritable Bowel Syndrome

Study Focus

Irritable Bowel Syndrome

Traditional Diet

Interventional

other

Sponsor & Location

Sheffield Teaching Hospitals NHS Foundation Trust

Timeline & Enrollment

N/A

Sep 01, 2023

Jul 01, 2024

134 participants

Primary Outcome

Proportion of IBS patients experiencing clinical response with traditional dietary advice vs. Mediterranean diet

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.

ICD-10 Classifications

Irritable bowel syndrome
Other and unspecified irritable bowel syndrome
Irritable bowel syndrome with mixed bowel habits [IBS-M]
Irritable bowel syndrome with predominant constipation [IBS-C]
Irritable bowel syndrome with predominant diarrhoea [IBS-D]

Data Source

ClinicalTrials.gov

NCT05985018

Non-Device Trial