Trial Details

Not Recruiting
Basic Information
Clinical ID c3107
Identifier ISRCTN98226923
Trial Title Fermentable dietary carbohydrates as triggers of functional gut symptoms in patients with inflammatory bowel disease: a randomised controlled crossover trial
Trial URL Visit Original Page
Study Information
Study Results

No results available

Conditions Inflammatory bowel disease (Crohn?'s disease and ulcerative colitis) Digestive System Noninfective inflammatory bowel disease
Interventions Interventions as of 06/02/2017: Eligible participants are allocated to undergo four dietary carbohydrate Fermentable Oligo-Di-Monosaccharides and Polyols (FODMAP) challenges in a random order. Each challenge lasts for 3 days, followed by at least 4 days washout. Participants record gastrointestinal symptoms and stool frequency and consistency during each challenge and on the final day of the washout period. Participants and researchers are blinded to the order of challenges. An online random number generator is used to produce the randomisation sequences. 1. Test: Fermentable carbohydrate drink containing 12 grams of fructans 2. Test: Fermentable carbohydrate drink containing 6 grams of galactooligosaccharides 3. Test: Fermentable carbohydrate drink containing 6 grams of sorbitol 4. Control: Fermentable carbohydrate drink containing 12 grams of glucose Interventions as of 23/04/2014: Each participant will complete all four dietary carbohydrate Fermentable Oligo-Di-Monosaccharides and Polyols (FODMAP) challenges in a random order: 1. Test: Fermentable carbohydrate drink containing 12 grams of fructans 2. Test: Fermentable carbohydrate drink containing 6 grams of galactooligosaccharides 3. Test: Fermentable carbohydrate drink containing 6 grams of sorbitol 4. Control: Fermentable carbohydrate drink containing 12 grams of glucose Original interventions: Each participant will complete all four dietary carbohydrate Fermentable Oligo-Di-Monosaccharides and Polyols (FODMAP) challenges in a random order: 1. Test: Fermentable carbohydrate drink containing 12 grams of fructans 2. Test: Fermentable carbohydrate drink containing 6 grams of galactooligosaccharides 3. Test: Fermentable carbohydrate drink containing 2 grams of sorbitol 4. Control: Fermentable carbohydrate drink containing 12 grams of glucose
Participant Information
Sponsor King's College London (UK)
City -
Country/Region United Kingdom
Enrollment Criteria
Sex Requirement ALL
Age Requirement -
Study Design
Study Type Interventional
Phase Not Available
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date -