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

NCT02107625 | Completed

• 1 other identifier: KRIBS1
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Irritable Bowel Syndrome

Keywords

Defecation; Abdominal pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Diet A i.e. Low FODMAP diet

EXPERIMENTAL

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

Diet B, i.e. Traditional IBS diet

EXPERIMENTAL

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

Interventions

Diet A i.e. Low FODMAP diet BEHAVIORAL

Diet A i.e. Low FODMAP diet

Diet B, i.e. Traditional IBS diet BEHAVIORAL

Diet B, i.e. Traditional IBS diet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• IBS diagnosis
• Adult (over 18 years)
• Be able to read/understand/write swedish

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Göteborg University: lead
• Karolinska Institutet: collaborator
• Aleris Specialistvård Sabbatsberg: collaborator

Related Publications (5)

• Nybacka S, Colomier E, Pall Hreinsson J, Storsrud S, Tack J, Tornblom H, Simren M. Dietary Intake and Quality in Irritable Bowel Syndrome: A Comparative Study With Controls and the Association With Symptom Severity. Am J Gastroenterol. 2024 Nov 27;120(9):2154-2164. doi: 10.14309/ajg.0000000000003249.

  PMID: 39601420 DERIVED

• 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.

  PMID: 34634050 DERIVED

• 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.

  PMID: 30838348 DERIVED

• 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.

  PMID: 28416515 DERIVED

• 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.

  PMID: 26255043 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome; Abdominal Pain

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Hans Törnblom, MD, PhD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 4, 2014
• First Posted: April 8, 2014
• Study Start: August 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: August 20, 2015

Record last verified: 2015-08