- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02107625
Traditional Dietary Advice Versus a Low FODMAP Diet Intake in IBS Patients (KRIBS)
August 19, 2015 updated by: Hans Törnblom, Göteborg University
A Multi-centre, Randomized, Single-blind, Comparative Trial: Traditional Dietary Advice Versus a Low FODMAP Diet Intake in IBS Patients
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
75
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
|
Experimental: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symptom alleviation through the questionnaire IBS-SSS
Time Frame: 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.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Nybacka S, Storsrud S, Liljebo T, Le Neve B, Tornblom H, Simren M, Winkvist A. Within- and Between-Subject Variation in Dietary Intake of Fermentable Oligo-, Di-, Monosaccharides, and Polyols Among Patients with Irritable Bowel Syndrome. Curr Dev Nutr. 2018 Dec 24;3(2):nzy101. doi: 10.1093/cdn/nzy101. eCollection 2019 Feb.
- Nybacka S, Simren M, Storsrud S, Tornblom H, Winkvist A, Lindqvist HM. Changes in serum and urinary metabolomic profile after a dietary intervention in patients with irritable bowel syndrome. PLoS One. 2021 Oct 11;16(10):e0257331. doi: 10.1371/journal.pone.0257331. eCollection 2021.
- Bennet SMP, Bohn L, Storsrud S, Liljebo T, Collin L, Lindfors P, Tornblom H, Ohman L, Simren M. Multivariate modelling of faecal bacterial profiles of patients with IBS predicts responsiveness to a diet low in FODMAPs. Gut. 2018 May;67(5):872-881. doi: 10.1136/gutjnl-2016-313128. Epub 2017 Apr 17.
- Bohn L, Storsrud S, Liljebo T, Collin L, Lindfors P, Tornblom H, Simren M. Diet low in FODMAPs reduces symptoms of irritable bowel syndrome as well as traditional dietary advice: a randomized controlled trial. Gastroenterology. 2015 Nov;149(6):1399-1407.e2. doi: 10.1053/j.gastro.2015.07.054. Epub 2015 Aug 5.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2013
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
April 4, 2014
First Submitted That Met QC Criteria
April 7, 2014
First Posted (Estimate)
April 8, 2014
Study Record Updates
Last Update Posted (Estimate)
August 20, 2015
Last Update Submitted That Met QC Criteria
August 19, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KRIBS1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Diet A i.e. Low FODMAP diet
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Ashok TutejaUnited States Department of DefenseUnknown
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Northwestern UniversityWithdrawn
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Cantonal Hospital of St. GallenCompletedIBS - Irritable Bowel Syndrome
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Queen's UniversityUnknownIrritable Bowel Syndrome With Diarrhea
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Hospital General de MexicoUnknownIBS - Irritable Bowel Syndrome | UC - Ulcerative Colitis | IBD - Inflammatory Bowel DiseaseMexico
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Beth Israel Deaconess Medical CenterEnrolling by invitation
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Ohio State UniversityCompletedAutism Spectrum DisorderUnited States
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University of NottinghamKing's College LondonCompletedIrritable Bowel SyndromeUnited Kingdom
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University of AarhusCompletedIrritable Bowel Syndrome | Endometriosis | Visceral Syndrome | Visceral HypersensitivityDenmark
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University of Erlangen-Nürnberg Medical SchoolCompleted