NAZA - Nottingham/Astra ZenecA Prospective IBD Cohort Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorUniversity of Nottingham
About this trial
The goal of this observational study is to learn about the comparisons of inflammatory markers between IBD and non-IBD (control) participants.
The main question it aims to answer is:
Are there differences in inflammatory markers between IBD and non-IBD (control) participants.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
Inability to give informed consent
Any positive result from previous screening for serum hepatitis B surface antigen, hepatitis C or human immunodeficiency virus (HIV)
An ongoing infection requiring treatment
Clinical evidence of active COVID infection and/or evidence of active COVID determined by local standard care procedures
Trial population
A cohort study in patients with moderate to severely active Crohn's 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 vedolizumab for UC or onto anti-TNFα therapy or ustekinumab or upadacitinib 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 or on any hospital/ medical/ clinical screening list or any other appropriate list with no pathology found on examination.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
240 Participants
are grouped into 6 trial groups6
Trial groupsSee each trial group below.
Group A: Crohn's Disease - anti-TNFα therapy
Group B: Crohn's Disease - ustekinumab
Group C: Crohn's Disease - upadacitinib
Group D: Ulcerative Colitis - anti-TNFα therapy
Group E: Ulcerative Colitis - vedolizumab
Group F: Control non-IBD
Trial outcomes
Primary outcomes
1
The comparison of the IL-23/Th17 inflammatory axis between IBD and healthy control samples
Time frame
Baseline, Month 3 and Month 12Secondary outcomes
1
Characterisation of IL-23/Th17 inflammatory axis within IBD biosamples stratified by prior biologic exposure
Time frame
Baseline, Month 3 and Month 122
Comparison of mRNA sequencing readouts, characterisation of tissue and immune cell populations, characterisation of protein expression and characterisation of microbial species in the stool and tissue
The above will be stratified by disease type and status, demographic features of the participant, biologic exposure, clinical and endoscopic response to treatment
Time frame
Baseline, Month 3 and Month 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Nottingham
Lead sponsor
Nottingham University Hospitals NHS Trust
Collaborator
Source ClinicalTrials.gov