Extract

Background and study aims Inflammatory bowel disease (IBD) is a chronic relapsing remitting disease characterised by inflammation of the gut. Between 35% and 57% of patients with IBD in remission also report a range of gut symptoms similar to those experienced in functional bowel disorders, including irritable bowel syndrome (IBS), such as abdominal pain, bloating and diarrhoea. These symptoms are not associated with underlying inflammation of the disease, but may result in reduced quality of life. There is growing evidence for the use of a diet low in fermentable carbohydrates (the low FODMAP diet) for the management of functional gut symptoms (FGS) in patients with IBS. There is early evidence for the use of this diet in patients with IBD who have FGS during inactive disease; however, there are no studies published in this area. The aim of this study is to find out whether IBD patients are sensitive to individual fermentable dietary carbohydrates (FODMAPs). Patients receive drinks containing common dietary carbohydrates and symptom response is compared with a placebo (dummy) challenge. Who can participate? Male and female adult IBD patients who have experienced a sustained improvement in their symptoms whilst following the low FODMAP diet, recruited from outpatient clinics at Guy’s and St Thomas’ NHS Foundation Trust, London, UK. What does the study involve? At an initial visit before the start of the study demographic and disease characteristics and details regarding FGS are collected. Measurements include disease activity scores, bowel habits diary, diet history, and stool and blood markers of inflammation. Participants continue on the low FODMAP diet throughout the study. Participants are then randomly allocated to a sequence of four carbohydrate test drinks. Participants take one measure of powdered carbohydrate mixed into water with breakfast or in the morning within a specified time frame. The drinks are consumed once daily for three days and a daily gut symptom and stool diary is kept to monitor symptoms. In addition, a daily adherence diary is kept. After the three test days participants are instructed on following a four-day washout phase in which they continue the diet with no test drinks. This phase is to ensure that symptoms have returned to as they were before the start of the intervention before starting the next test. This is repeated for each of the four test drinks. Once a participant has completed all four tests, they attend a final visit for an end of study blood and stool sample to recheck inflammation. Any adverse events are also recorded. What are the possible benefits and risks of participating? The main benefit of participating in the study is that patients learn which carbohydrates they are most sensitive to, enabling appropriate dietary changes to be made to help them manage their symptoms effectively. The low FODMAP diet is well tolerated, is not known to have any negative effects and is routinely used in clinical practice. Risk to patient safety is not expected. The main burden to participants is continuing a strict low FODMAP diet for the duration of the study, completing gut symptom and stool diaries, providing two blood and stool samples, and consuming the test drinks. The test drinks may induce symptoms that cause abdominal discomfort and/or a change in bowel habit, but the quantities of carbohydrates used in the test drinks are similar to those consumed in their previous ‘normal diet’ and symptoms are not expected to be greater than those experienced by patients before starting the diet. There are no safety concerns of consuming these dietary carbohydrates. Taking blood samples is a routine procedure used frequently in clinical practice. Participants may experience mild pain or discomfort during the procedure and may notice a small bruise or mild soreness for a few days afterwards. The procedure is performed by an experienced and trained phlebotomist. Where is the study run from? King'’s College London and Guy’s and St Thomas’ NHS Foundation Trust gastroenterology outpatient clinics (UK). When is the study starting and how long is it expected to run for? March 2014 to January 2017 Who is funding the study? King's College London (UK) Who is the main contact? 1. Prof. Kevin Whelan 2. Dr Peter Irving [email protected] 3. Alexis Prince [email protected]

Inclusion criteria

• inflammatory bowel disease (Crohn’s disease and ulcerative colitis)

Links

• ictrp
• isrctn