Traditional Dietary Advice Versus a Low FODMAP Diet Intake in IBS Patients

Study Overview
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Brief Summary
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The purpose of this study is to to assess if the new diet with a low-FODMAP(Fermented Oligo-, Di-, Monosaccharides And Polyols) -content yields a milder symptom picture in IBS patients compared to traditionally dietary advice in IBS. The study also aim to investigate patients compliance to either dietary advices. Further, the investigators aim to find out if IBS patients with different symptoms are alleviated in different ways, to be able to individualize the dietary advices to result in a more optimal symptom relief in each patient in the future.

Official Title
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A Multi-centre, Randomized, Single-blind, Comparative Trial: Traditional Dietary Advice Versus a Low FODMAP Diet Intake in IBS Patients

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Behavioral: Diet A i.e. Low FODMAP diet
* Behavioral: Diet B, i.e. Traditional IBS diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: IBS diagnosis Adult (over 18 years) Be able to read/understand/write swedish Exclusion Criteria: Severe heart failure Severe liver disease Severe neurologic disease Severe psychological disease Severe gastrointestinal disease (i.e. celiac disease, IBD (inflammatory bowel disease) e.g.)

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diet A i.e. Low FODMAP diet<br>The patients are thoroughly informed verbally and in writing how to eat according to the low FODMAP diet. The diet imply restrictions in carbohydrate intake and the patients need to follow a list with yes/no-foods for 4 weeks. | Behavioral: Diet A i.e. Low FODMAP diet<br> <br> |
| Experimental: Diet B, i.e. Traditional IBS diet<br>The patients are thoroughly informed verbally and in writing how to eat according to traditional IBS dietary advices. The diet imply adapting to regular dietary habit with meals 6 times a day, no to big meals, to chew food thoroughly, to peel fruits and vegetables, no carbonated beverages, no chewing gum, no soft drinks, no sugar-free candies, or cookies. Reduce spicy foods, coffee, alcohol, onion, pulses, and fatty foods. Keep strictly to the dietary advice for 4 weeks. | Behavioral: Diet B, i.e. Traditional IBS diet<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom alleviation through the questionnaire IBS-SSS | IBS-SSS i.e. the IBS Severity Scoring System. To assess the possible change of severity of IBS symptoms. The overall IBS score is calculated ranging from 0 to 500. A higher score implicates more severe symptom. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Defecation, Abdominal pain