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

• ClinicalTrials.gov Identifier: NCT02107625
• Recruitment Status: Completed
• First Posted: April 8, 2014
• Last Update Posted: August 20, 2015
• Sponsor: Göteborg University
• Collaborators: Karolinska Institutet; Aleris Specialistvård Sabbatsberg
• Information provided by (Responsible Party): Hans Törnblom, Sahlgrenska University Hospital, Sweden

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Irritable Bowel Syndrome	Behavioral: Diet A i.e. Low FODMAP diet; Behavioral: Diet B, i.e. Traditional IBS diet	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Multi-centre, Randomized, Single-blind, Comparative Trial: Traditional Dietary Advice Versus a Low FODMAP Diet Intake in IBS Patients
• Study Start Date: August 2013
• Actual Primary Completion Date: January 2015
• Actual Study Completion Date: January 2015

Arms and Interventions

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.	Behavioral: Diet A i.e. Low FODMAP diet
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.	Behavioral: Diet B, i.e. Traditional IBS diet

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.)

Contacts and Locations

Sponsors and Collaborators

Göteborg University

Karolinska Institutet

Aleris Specialistvård Sabbatsberg

Investigators

• Principal Investigator: Hans Törnblom, MD, PhD; Sahlgrenska University Hospital, Sweden

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

• Responsible Party: Hans Törnblom, MD, PhD, Sahlgrenska University Hospital, Sweden
• ClinicalTrials.gov Identifier: NCT02107625
• Other Study ID Numbers: KRIBS1
• First Posted: April 8, 2014
• Last Update Posted: August 20, 2015
• Last Verified: August 2015

Keywords provided by Hans Törnblom, Sahlgrenska University Hospital, Sweden:

Defecation; Abdominal pain

Additional relevant MeSH terms:

Irritable Bowel Syndrome; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases