Nottingham/Astra ZenecA prospective IBD cohort study
Research type
Research Study
Full title
Nottingham/Astra ZenecA prospective IBD cohort study
IRAS ID
306306
Contact name
Gordon Moran
Contact email
Sponsor organisation
University of Nottingham
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
2 years, 6 months, 2 days
Research summary
A cohort study in patients with moderate to severely active Crohns Disease (CD) and Ulcerative Colitis (UC) who are switching to new targeted biologic therapy (with a different mode of action), onto either anti-TNFα therapy or a biologic treatment of either vedolizumab for UC or vedolizumab or ustekinumab for CD and undergoing routine endoscopic assessments as part of normal clinical practice we will also recruit participants without these conditions (controls) who are due for a lower GI colonoscopy as part of the UK national bowel cancer screening programme.
The study aims to enrol 40 control participants, 120 with CD and 80 with UC. To ensure even distribution across the study groups, approximately 40, but no less than 30 participants should be recruited into each treatment arm. CD participants will be stratified by disease location site of disease.
Controls will provide a blood sample and stool sample as well as extra tissue biopsies taken at their standard care colonoscopy. (Baseline)
-CD & UC patients will provide blood and stool samples at 3 timepoints (baseline, 3mths, 12mths) as well as extra tissue biopsies taken at their standard care endoscopy within 12mths. We will also video-record the level of inflammation at endoscopy for analysis.
Samples will be analysed to characterise any observable traits (phenotype) and molecular variability in patients which may be associated with clinical response to the treatment.
We hope the information we get from this study may help improve our understanding of Inflammatory Bowel Diseases (IBD) and help us to develop better ways of treating the condition and predicting the course of the disease and how patients may respond to different treatments.REC name
West of Scotland REC 1
REC reference
22/WS/0099
Date of REC Opinion
15 Aug 2022
REC opinion
Further Information Favourable Opinion