Traditional Dietary Advice Vs. Mediterranean Diet in IBS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-30

Study Completion Date

2024-12-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Mediterranean Approach to Low FODMAP Diet (MED-LFD) for Managing IBS Symptoms

NCT03997708

Irritable Bowel Syndrome With Diarrhea

COMPLETED NA

A Study Comparing the Effectiveness and Convenience of Dietary Therapy for Irritable Bowel Syndrome (IBS)

NCT04072991

Irritable Bowel Syndrome

COMPLETED NA

Mediterranean Diet and the Gut Microbiome

NCT03269032

Irritable Bowel Syndrome

COMPLETED NA

A Clinical Trial Evaluating Diets for IBS

NCT05831306

Irritable Bowel Syndrome

UNKNOWN NA

The Effects of FODMAPs in Patients With Irritable Bowel Syndrome

NCT05182593

Irritable Bowel Syndrome

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Irritable Bowel Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Traditional Dietary Advice

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

Group Type ACTIVE_COMPARATOR

Traditional Diet

Intervention Type OTHER

Provided as an educational leaflet

Mediterranean Diet

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

Group Type ACTIVE_COMPARATOR

Mediterranean Diet

Intervention Type OTHER

Provided as an educational leaflet

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Traditional Diet

Provided as an educational leaflet

Intervention Type OTHER

Mediterranean Diet

Provided as an educational leaflet

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No