A Clinical Trial Evaluating Diets for IBS

Study Overview
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Brief Summary
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Diet and lifestyle changes are the recommended first line treatments for symptom relief in irritable bowel syndrome (IBS). Currently the only diet that is widely recommended and for which there is good evidence of efficacy in IBS is one low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (low-FODMAP). While effective, the Low-FODMAP diet is burdensome and costly to patients and in clinical practice adherence to FODMAP restriction is less than optimal. Further, patients who respond to a FODMAP restriction often are reluctant to reintroduce more FODMAPs into their diet, which may deprive them of foods, particularly fruits and vegetables with important health benefits. Therefore, there is a need for other dietary interventions for IBS that are less burdensome to patients. This clinical trial assesses the efficacy of two dietary interventions.

Official Title
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A Randomized Clinical Trial Evaluating Two Different Diets for IBS

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Other: Diet A
* Other: Diet B


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Patients with IBS-D diagnosed per Rome IV questionnaire and without any unexplained alarm features (rectal bleeding, weight loss, nocturnal symptoms, family history of inflammatory bowel disease or celiac disease) Aged 18-65 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% compliance in daily diary entries during the 7-day screening period Exclusion criteria Subjects adhering to a dietary IBS-treatments such as the low-fat diet, low FODMAP diet, or gluten-free diet within the past 6 months Subjects with a known food allergy to eggs, peanuts, or milk (subjects with lactose intolerance who are experiencing IBS symptoms while on a lactose-free diet will not be excluded from the study). Subjects with a history of insulin-dependent or non-insulin-dependent diabetes Subjects with a known history of 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. BMI < 18.5

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diet A<br>Modified Diet A | Other: Diet A<br>* Modified Diet A<br>|
| Experimental: Diet B<br>Modified Diet B | Other: Diet B<br>* Modified Diet B<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal Pain Intensity | Proportion of weekly responders. A weekly responder is defined as a decrease in weekly average of worst abdominal pain in the past 24 hours score of at least 30% compared with baseline. | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal Discomfort Intensity | Proportion of weekly responders. A weekly responder is defined as a decrease in worst abdominal discomfort in the past 24 hours score of at least 30% compared with baseline. | 28 days | 
| Composite Score | Proportion of weekly composite responders. A weekly composite responder is defined as a subject who experiences a decrease in the weekly average of worst abdominal pain in the 24 hours score of at least 30% compared with baseline AND who experiences a 50% or greater reduction in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline | 28 days | 
| Abdominal Bloating Intensity | Proportion of weekly responders. A weekly responder is defined as a decrease in worst abdominal bloating in the past 24 hours score of at least 30% compared with baseline. | 28 days | 
| Stool Consistency | Weekly responder. A weekly responder is defined as a decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Bristol Stool Form Scale Type 6 or Type 7 compared with baseline. | 28 days | 
| Irritable Bowel Syndrome - Symptom Severity Score | Proportion of subjects who experience a 50-point and 100-point decrease in IBS-SSS compared with baseline. | 28 days | 
| Irritable Bowel Syndrome - Symptom Severity Score | Change in IBS-SSS as compared with baseline. | 28 days | 
| Adequate Relief | Proportion of subjects who experience adequate relief compared with baseline. | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dietary intervention, lifestyle intervention