GI CHARACTER
Research type
Research Study
Full title
Gastrointestinal diseases CHARACTERIZATION study
IRAS ID
138976
Contact name
Jack Satsangi
Contact email
Clinicaltrials.gov Identifier
FP7 grant agreement number, 2858546
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
We propose a collaborative study to advance the understanding of the inflammatory bowel diseases (IBD) Crohn’s Disease and Ulcerative Colitis with the aim of detecting the illness in its early phase and identifying novel ways to accurately characterise the disease and stratify the risk in individual patients. This is turn will allow better disease control with longer symptom free periods and help prevent serious complications that are associated with longstanding IBD.
This cohort study requires the recruitment of a large number of patients who have recently been diagnosed with IBD as well as symptomatic individuals and healthy controls. We plan to recruit patients from 0-75 years of age at clinic appointments or on the day of endoscopy having sent out a patient information leaflet before the visit. Consenting participants will be asked to provide samples of stool, saliva, blood, urine and gut tissue for a variety of tests including genetic tests. Some samples may be processed abroad as this is a multi-centre collaborative project with international scientific research partners. All samples will be collected at the time of other diagnostic tests being performed as part of routine clinical practice. Additional invasive procedures will not be requested. We will also aim to recruit healthy controls (adults only, members of staff from University and NHS sites) who would volunteer to give samples of blood, stool, urine and saliva.
This study is funded via a grant from the European Union (FP7 framework). Current techniques for diagnosis and disease assessment including endoscopy and Computed Tomography (CT) are intrusive, potentially unpleasant and carry a radiation risk. The aim of this study is to expand current knowledge of genetic factors predisposing people to IBD and to identify new biomarkers to help diagnose and predict disease course.
REC name
South East Scotland REC 02
REC reference
15/SS/0057
Date of REC Opinion
24 Apr 2015
REC opinion
Further Information Favourable Opinion