Clinical trial NCT05985018: Traditional Dietary Advice Vs. Mediterranean Diet in IBS
Official title: A Randomized Trial of Traditional Dietary Advice Versus Mediterranean Diet in Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of IBS patients experiencing clinical response with traditional dietary advice vs. Mediterranean diet
timeFrame: Baseline to Week 6
Secondary outcomes:
measure: Changes in individual items of the IBS-SSS
timeFrame: Baseline to Week 6
measure: Changes in Anxiety and Depression
timeFrame: Baseline to Week 6
measure: Changes in Somatic Symptom reporting
timeFrame: Baseline to Week 6
measure: Changes in quality of life
timeFrame: Baseline to Week 6
measure: Dietary satisfaction to assigned intervention
timeFrame: Week 6
measure: Adherence to the Mediterranean diet
timeFrame: Week 6
measure: Changes in nutritional intake
timeFrame: Baseline to Week 6
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
state: South Yorkshire
Study officials:
affiliation: Sheffield Teaching Hospitals NHS Foundation Trust
name: Imran Aziz
role: PRINCIPAL_INVESTIGATOR
References: