UK Inflammatory Bowel Disease Inception Cohort Study
Research type
Research Study
Full title
UK Inflammatory Bowel Disease Inception Cohort Epidemiological Study (UNITE)
IRAS ID
153327
Contact name
Ravi Misra
Contact email
Sponsor organisation
London North West NHS Trust
Clinicaltrials.gov Identifier
V2 15/10/14, Patient information sheet
Duration of Study in the UK
10 years, 0 months, 1 days
Research summary
Ulcerative Colitis (UC) and Crohn’s Disease (CD) are chronic inflammatory bowel conditions, collectively known as Inflammatory Bowel Disease (IBD), the cause of which is unknown. Proposed hypotheses encompass an interaction between genetic predisposition and environmental factors. Previous studies have demonstrated a higher incidence (number of new cases) and more aggressive disease course in ethnic groups. Studying changing incidence of disease in ethnic populations who have migrated from abroad offers a unique opportunity to examine dietary and environmental factors that may contribute to disease presentation. We propose a multi-centre prospective cohort study to enrol all new cases of IBD and study the contribution of ethnic diversity. The study will be designed to examine the role of diet and the gut bacteria and define variables that may predict response to therapy by integrating clinical data with stool sample collections to examine the gut microbiota (the population of gut bacteria living in our intestine). The newly diagnosed inception cohort will be followed up for specific outcomes such as adverse drug events, surgery, pregnancy, and disease complications including cancer. The study will generate a collaborative network of UK-based centres to collect data on the epidemiology and outcomes of IBD via a standardised, validated web based database.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
14/EM/1290
Date of REC Opinion
10 Dec 2014
REC opinion
Further Information Favourable Opinion