Extrait

Background and study aims Ulcerative colitis (UC) is a condition which cause long-term inflammation (swelling) in the colon and rectum (the last part of the large intestine). The exact cause is unknown, but some think that it may be because the immune system attacks the healthy tissue of the gut (autoimmune disease). There is currently no cure, and so the main aim of treatment is to reduce the symptoms (remission) and prevent the disease from “flaring up” and becoming active again. Even when the disease is in remission, many patients still experience symptoms such as bloating, diarrhoea and abdominal (tummy) pain. Studies looking at UC in people and in the lab have found that some types prebiotics (an ingredient in some foods which helps increase the amount of 'good' bacteria in the gut) may help reduce inflammation by signalling to the immune system through specific pathways. The way this works is unclear however and requires further research. The aim of this study is to find out whether consuming prebiotics daily has an effect on gut inflammation in people with UC. Who can participate? Men and women aged 16-65 who have ulcerative colitis. What does the study involve? All participants are provided with a six week supply of Bimuno prebiotic dietary supplement and are asked to take this daily for six weeks. Before starting and at the end of the trial participants are asked to fill in a food and bowel diary to tell the researchers about what their normal diet, gut symptoms and bowel habits are like in to have information to compare the results to. Participants provide blood, stool and urine samples at the start of the trial and after six weeks of taking the supplements to measure markers of immunity and inflammation. What are the possible benefits and risks of participating? Bimuno is a prebiotic widely available in the UK, participants will be provided with this for free for six weeks to supplement their normal diet. The main researcher is a qualified Dietitian and will be able to answer questions about diet and at the end of the study provide any dietary advice that may be relevant to the participant (not during the trial though as diet should stay the same). Their are no anticipated risks to taking part. Where is the study run from? 1. Guy's Hospital, London (UK) 2. Royal London Hospital, London (UK) When is the study starting and how long is it expected to run for? May 2016 to March 2018 Who is funding the study? 1. Clasado Ltd (UK) 2. King's College London, Diabetes and Nutritional Sciences Division (UK) Who is the main contact? Miss Bridgette Wilson [email protected]

Critère d'inclusion

• Ulcerative colitis

Liens

• isrctn