NCT05985018

Traditional Dietary Advice Vs. Mediterranean Diet in IBS

A Randomized Trial of Traditional Dietary Advice Versus Mediterranean Diet in Irritable Bowel Syndrome
Sheffield Teaching Hospitals NHS Foundation Trust·ClinicalTrials.gov·otherNot yet recruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Irritable Bowel Syndrome
Drug/Device/Intervention
Traditional Diet
Study type
Interventional
Intervention type
other
Sponsor & location
Primary sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Timeline & enrollment
Phase
N/A
Start date
Sep 01, 2023
End date
Jul 01, 2024
Enrollment
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 syndromeOther and unspecified irritable bowel syndromeIrritable 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
Registry
ClinicalTrials.gov
Trial ID
NCT05985018
Type
Non-Device Trial
About this record

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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