PREdiCCt
Research type
Research Study
Full title
The prognostic effect of environmental factors in Crohn's and Colitis
IRAS ID
183889
Contact name
CW Lees
Contact email
Sponsor organisation
University of Edinburgh
Clinicaltrials.gov Identifier
REC, 16/WM/0152
Duration of Study in the UK
4 years, 1 months, 31 days
Research summary
Inflammatory bowel disease (IBD) is an umbrella term that includes Crohn’s disease and ulcerative colitis. It affects about 1 in 200 (mostly young) people in the UK. It can make sufferers quite weak, typically giving them episodes (often referred to as flares) of abdominal pain, bloody diarrhoea, nausea and lethargy. The symptoms can be extreme enough to affect all aspects of day to day living. This Study aims to follow a group of 1500 patients, 750 with UC and 750 with Crohn's disease over a two year period from a point of remission to see if environmental factors and gut bacteria influence subsequent disease flares. Patients with a confirmed diagnosis, aged six years or more can participate in this study through attendance at collaborating hospital GI clinics. Information relating to diet, environment and lifestyle changes will be collected via a secure website every month and samples of saliva, blood and stool will be collected at study entry (either during routine clinic visit following screening and consent or, for the saliva and stool samples, from home using special postal kits). Samples will be collected again if possible at first flare in the same manner. In addition some additional information will also be collected following a flare including the course of treatment given. Every patient will be followed up for two years. All paperwork and web information will be age appropriate.
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
16/WM/0152
Date of REC Opinion
22 Mar 2016
REC opinion
Favourable Opinion