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

Irritable Bowel Syndrome Clinical Trial

— KRIBS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02107625
• Other study ID #: KRIBS1
• Status: Completed
• Phase: N/A
• First received: April 4, 2014
• Last updated: August 19, 2015
• Start date: August 2013
• Est. completion date: January 2015

Study information

• Verified date: August 2015
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome

Intervention

Behavioral:
• Diet A i.e. Low FODMAP diet

• Diet B, i.e. Traditional IBS diet

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Göteborg University	Aleris Specialistvård Sabbatsberg, Karolinska Institutet

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No