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

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Behavioral: Diet B, i.e. Traditional IBS diet; Behavioral: Diet A i.e. Low FODMAP diet

• Registration Number: NCT02107625
• Lead Sponsor: Göteborg University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2014-04-04
• Study First Submitted QC: 2014-04-07
• Study First Posted: 2014-04-08
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-19
• Last Update Posted: 2015-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diet B, i.e. Traditional IBS diet	Diet B, i.e. Traditional IBS diet	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.
Diet A i.e. Low FODMAP diet	Diet A i.e. Low FODMAP diet	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.

Primary Outcome Measures

Name	Time	Method
Symptom alleviation through the questionnaire IBS-SSS	4 weeks	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.