Fermentable dietary carbohydrates as triggers of functional gut symptoms in patients with inflammatory bowel disease

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2014
INTERVENTION: 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 CONDITION: Inflammatory bowel disease (Crohn?'s disease and ulcerative colitis) ; Digestive System ; Noninfective inflammatory bowel disease PRIMARY OUTCOME: To find out whether FGS are adequately controlled following rechallenge with individual FODMAPs compared with a placebo, glucose. This will be measured by a Global Symptom Question ?Do you currently have satisfactory relief of your gut symptoms?? with a 'yes' or 'no' response. This will be measured at baseline, for 3 days during each test and on day 4 of the washout phase to ensure symptoms have returned to baseline. SECONDARY OUTCOME: 1. Ratings and mean scores for individual symptoms during each test phase, measured by the Gastrointestinal Symptom Rating Scale at baseline, for 3 days during each test and on day 4 of the washout phase.; 2. Faecal calprotectin and serum CRP levels, measures of inflammation, measured at baseline and at the end of the trial INCLUSION CRITERIA: 1. Men and women aged 18 years or over 2. Individuals able to give informed consent 3. Diagnosis of IBD confirmed by standard clinical, histological and radiological criteria 4. Diagnosis of IBD for duration of at least 6 months. IBD in remission as defined by physician global assessment, patient report and two markers of absence of inflammation: C‐reactive protein (CRP) <10mg/l and faecal calprotectin <250µg/g. 5. Stable medications (see exclusion criteria), no recent surgery (see exclusion criteria) and stable symptoms for at least 2 months 6. Diagnosis of functional bowel disorder as defined by Rome III criteria (IBS or functional bloating or functional diarrhoea or functional abdominal pain syndrome) with marked and sustained improvement of these symptoms on the low fermentable carbohydrate diet 7. A willingness to participate
Epistemonikos ID: 0dcf29ceaa6ecc797a4aa614a209b473c9602711
First added on: Aug 23, 2024