Evaluating the Efficacy of the Mediterranean Diet to the Low- Fermentable, Oligosaccharides, Disaccharides, Monosaccharides, and Polyols (FODMAP) Diet in Treating Irritable Bowel Syndrome(IBS)

Study Overview
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Brief Summary
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This study is being completed to determine if the Mediterranean (MD) and low FODMAP (fermentable, oligosaccharides, disaccharides, monosaccharides, and polyols) diets are comparable in the effectiveness to treat Irritable Bowel Syndrome (IBS). The study team hypothesizes that: The low FODMAP and Mediterranean groups will achieve a similar improvement in abdominal pain Both groups will achieve similar improvements in bloating, overall IBS symptom severity, and adequate relief

Official Title
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Evaluate and Compare the Clinical Efficacy of the Mediterranean Diet to the Low-FODMAP Diet in Treating Irritable Bowel Syndrome

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Other: Diet low in all FODMAP groups
* Other: Diet - Mediterranean


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with IBS-D (diarrhea-predominant IBS) or IBS-M (IBS with mixed subtype) diagnosed per Rome IV questionnaire and without any unexplained alarm features (rectal bleeding, weight loss, nocturnal symptoms, personal history of celiac disease, microscopic colitis, inflammatory bowel disease) Aged 18-70 years at the time of screening Weekly average of worst daily (in the past 24 hours) abdominal pain score of ≥3.0 on a 0-to-10-point scale At least 80 percent compliance in daily questionnaire entries during the 7-day screening period Exclusion Criteria: Subjects adhering to any dietary IBS treatment such as the low-fodmap diet, or gluten-free diet, Mediterranean currently or within the past 6 months Subjects with a known food allergy to eggs, seafood, peanuts, tree nuts or milk (subjects with lactose intolerance that are experiencing IBS symptoms while on a lactose-free diet will not be excluded from the study). Subjects with a history of poorly controlled insulin-dependent or non-insulin-dependent diabetes Subjects with a known history of organic Gastrointestinal (GI) disease (i.e., celiac disease, inflammatory bowel disease or microscopic colitis) Subjects with a history of an eating disorder requiring medical or behavioral treatment within the past 10 years. Subjects with prior small bowel or colonic surgery (excluding appendectomy or cholecystectomy if over 6 months since these 2 procedures) Oral antibiotic use in the past 3 months Any planned significant changes in dietary or exercise regimen within 30 days prior to Screening or during the study. Currently pregnant or breastfeeding.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects meeting all eligibility criteria will be randomized in a 1:1 ratio to receive either the MD or the LFD for a four-week period.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diet low in all FODMAP groups<br> | Other: Diet low in all FODMAP groups<br>* Randomized participants will eat this diet for 4 weeks (all meals and snacks will be provided). Participants will only eat the study food for this intervention. Participants will be asked to complete surveys, food diaries, and have blood and stools samples pre and post treatment.<br>|
| Experimental: Diet - Mediterranean<br> | Other: Diet - Mediterranean<br>* Randomized participants will eat this diet for 4 weeks (all meals and snacks will be provided). Participants will only eat the study food for this intervention. Participants will be asked to complete surveys, food diaries, and have blood and stools samples pre and post treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients that are responders based on the abdominal pain intensity score for at least 2 of the 4 weeks | The abdominal pain score is a single-question, 11-point numeric rating scale in which 0 represents no abdominal pain and 10 represents the worst possible abdominal pain. Once per day, subjects will report worst daily (in the past 24 hours) abdominal pain. Proportion of patients that would be weekly responders to abdominal pain for at least 2 of the 4 weeks. A weekly responder is defined as a decrease in the weekly average of worst abdominal pain in the past 24 hours score of at least 30% compared with baseline. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients that are weekly responders to adequate relief symptom assessment for at least 2 of the 4 weeks | Subjects will provide a binary (yes or no) response to rate the adequacy of relief of global IBS symptoms at the start of the study and weekly thereafter. Adequate relief - Proportion of patients that would be weekly responders to adequate relief symptom assessment for at least 2 of the 4 weeks. A weekly responder is defined as adequate relief in symptoms in at least 2 out of 4 weeks of the treatment period. | 4 weeks | 
| Proportion of patients that are weekly responders based on the Irritable Bowel Severity Scoring System (IBS-SSS) modified version for at least 2 of the 4 weeks | There are 5 questions that subjects will answer regarding their stomach and bowels. The total score that is calculated for this modified version (0-500). IBS-SSS - Proportion of weekly responders for at least 2 of the 4 weeks. A weekly responder is defined as a decrease in the weekly IBS-SSS score of at least 50 points compared with baseline. | 4 weeks | 
| Change in mean score of the Irritable Bowel Severity Scoring System (IBS-SSS) modified version | There are 5 questions that subjects will answer regarding their stomach and bowels. The total score that is calculated for this modified version (0-500). | Baseline, 4 weeks | 
| Proportion of patients that are weekly responders to bloating for at least 2 of the 4 weeks | The abdominal bloating score is a single-question, 11-point numeric rating scale in which 0 represents no abdominal bloating and 10 represents the worst possible abdominal bloating. Once per day, subjects will report their worst daily (in the past 24 hours) abdominal bloating. Bloating - Proportion of patients who would be weekly responders to bloating for at least 2 of the 4 weeks. A weekly responder is defined as a decrease in the weekly average of worst bloating in the past 24 hours score of at least 30% compared with baseline. The abdominal bloating score is a single-question, 11-point numeric rating scale in which 0 represents no abdominal bloating and 10 represents the worst possible abdominal bloating. Once per day, subjects will report their worst daily (in the past 24 hours) abdominal bloating | 4 weeks | 
| Proportion of patients that are weekly responders to stool consistency based on the Bristol Stool Scale (BSS) for at least 2 of the 4 weeks | A stool consistency weekly responder will be defined as a 50% or greater reduction in the number of days per week with at least one abnormal stool (defined as BSS 1 or 2 or 6 or 7) Stool consistency: Proportion of patients who would be weekly responders to stool consistency assessment for at least 2 of the 4 weeks. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low FODMAP Diet, Mediterranean Diet