A Comparison of Three Different Treatment Options for Irritable Bowel Syndrome

NCT02970591 | Completed

• 1 other identifier: Car-IBS 1511-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Irritable Bowel Syndrome is a common disease to which there is no curable treatment. Diet is considered to trigger symptoms associated with the clinical picture of IBS, and dietary treatment is thus believed to relieve the symptoms of IBS. As the disease is very heterogeneous in its manifestation, different treatment options might be indicated depending on the predominant symptom. To investigate the response to different dietary treatment options, a randomized controlled intervention trial will be carried out in adult patients (\>18 y) with IBS according to Rome IV criteria. The aim of this study is to compare the response to two different dietary treatments or optimized medical treatment.

Conditions

Irritable Bowel Syndrome

Keywords

FODMAPS; carbohydrates; metabolomics; microbiota

Outcome Measures

Primary Outcomes (1)

• The proportion (%) of patients who respond to treatment

  A responder is defined as having an IBS-SSS reduction \>50 points @ 4 weeks

  Baseline to 4 weeks

Secondary Outcomes (8)

• Change in symptom severity

  Baseline, 4 weeks, 3 and 6 months

• Determinants for GI symptoms by IBS-SSS

  Baseline, 4 weeks, 3 and 6 months

• Determinants for GI symptoms by GSRS-IBS

  Baseline, 4 weeks, 3 and 6 months

• Predictors of response to treatment

  Baseline to 4 weeks

• Adherence to allocated intervention

  Baseline, 4 weeks, 3 and 6 months

Other Outcomes (1)

• Qualitative assessment

  Approx. at 3 months follow-up

Study Arms (3)

Diet A

EXPERIMENTAL

Low carbohydrate diet

Other: Traditional dietary advice and low FODMAP content

Medical treatment

ACTIVE COMPARATOR

Optimized Medical treatment

Other: Optimized Medical treatment

Diet B

EXPERIMENTAL

Traditional dietary advice and low FODMAP content

Other: Low carbohydrate diet

Interventions

Traditional dietary advice and low FODMAP content OTHER

Traditional dietary advice according to the Brittish Dietetic Association including reducing the intake of fermentable carbohydrates.

Diet A

Low carbohydrate diet OTHER

Diet that contains a maximum of 10 energy percent of carbohydrates, 23 energy % proteins and 67 energy % fat.

Diet B

Optimized Medical treatment OTHER

Standard consultation by physician and if needed patients will receive medical treatment based on the most prominent symptom. Constipation: osmotic laxatives, linaclotide. Diarrhea: loperamid, bile acid binders. Pain: anti depressent, antispasmodics, linaclotide.

Medical treatment

Eligibility Criteria

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

You may qualify if:

• IBS according to ROME IV criteria, BMI 18-35, ability to communicate in Swedish, Gothenburg region resident

You may not qualify if:

• Heart, liver, neurologic or psychiatric disease or illness
• Serious gastrointestinal diseases
• Celiac disease
• Diabetes
• Other conditions or surgery that affects the gastrointestinal function
• Hyperlipidemia
• Food allergy or intolerance other than lactose
• Adherence to a specific diet
• Being pregnant or breastfeeding
• Previously been treated with any of the intervention arms, including having tested all of the pharmacological treatment options of relevance for the symptom profile of the patient

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Magnus Simren

Gothenburg, Non-US/Non-Canadian, 44331, Sweden

Location

Related Publications (3)

• Nybacka S, Tornblom H, Josefsson A, Hreinsson JP, Bohn L, Frandemark A, Weznaver C, Storsrud S, Simren M. A low FODMAP diet plus traditional dietary advice versus a low-carbohydrate diet versus pharmacological treatment in irritable bowel syndrome (CARIBS): a single-centre, single-blind, randomised controlled trial. Lancet Gastroenterol Hepatol. 2024 Jun;9(6):507-520. doi: 10.1016/S2468-1253(24)00045-1. Epub 2024 Apr 18.

  PMID: 38643782 DERIVED

• Nybacka S, Tornblom H, Simren M, Storsrud S. The Role of Carbohydrates in Irritable Bowel Syndrome: Protocol for a Randomized Controlled Trial Comparing Three Different Treatment Options. JMIR Res Protoc. 2022 Jan 17;11(1):e31413. doi: 10.2196/31413.

  PMID: 35037893 DERIVED

• Algera JP, Storsrud S, Lindstrom A, Simren M, Tornblom H. Gluten and fructan intake and their associations with gastrointestinal symptoms in irritable bowel syndrome: A food diary study. Clin Nutr. 2021 Oct;40(10):5365-5372. doi: 10.1016/j.clnu.2021.09.002. Epub 2021 Sep 9.

  PMID: 34560607 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Diet, Carbohydrate-Restricted

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 18, 2016
• First Posted: November 22, 2016
• Study Start: January 1, 2017
• Primary Completion: April 15, 2022
• Study Completion: April 29, 2022
• Last Updated: October 27, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)