Actively Recruiting
NAZA - Nottingham/Astra ZenecA Prospective IBD Cohort Study
Led by University of Nottingham · Updated on 2025-05-29
240
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Nottingham
Lead Sponsor
N
Nottingham University Hospitals NHS Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating differences in inflammatory markers between people with Inflammatory Bowel Diseases (IBD), including Crohn's Disease and Ulcerative Colitis, and those without IBD. This observational cohort study aims to improve understanding of IBD by comparing immune system activity and molecular features in patients and healthy controls. The study includes patients with moderate to severely active disease who are switching to new biologic treatments with different mechanisms of action. Patients with Crohn's Disease will switch to anti-TNFb1 therapy, ustekinumab, or upadacitinib, while patients with Ulcerative Colitis will switch to anti-TNFb1 therapy or vedolizumab. The specific biologic dose, frequency, and duration will be prescribed by their consultant as part of standard care. Control participants without IBD will undergo routine lower gastrointestinal colonoscopy as part of screening programs, with no biologic treatment. Participants will provide blood and stool samples at baseline, 3 months, and 12 months, and extra tissue biopsies will be collected during standard care endoscopies within 12 months. Researchers will analyze these samples to study the IL-23/Th17 inflammatory pathway and other molecular and microbial characteristics. The study monitors inflammatory markers and immune responses over time to better predict treatment responses and disease progression. The total study duration for participants is 12 months.
CONDITIONS
Brief Title
NAZA - Nottingham/Astra ZenecA Prospective IBD Cohort Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent given
- Aged 16 years or older
- For Crohn's Disease patients: active disease defined by specific clinical markers, switching to anti-TNFb1, ustekinumab, or upadacitinib
- For Ulcerative Colitis patients: active disease defined by specific clinical markers, switching to anti-TNFb1 therapy or vedolizumab
- Non-IBD participants attending lower GI colonoscopy with no pathology found on examination
You will not qualify if you...
- Unable to give informed consent
- Positive screening for hepatitis B surface antigen, hepatitis C, or HIV
- Ongoing infection requiring treatment
- Active COVID infection
- Participation in a pharmacological clinical study within 3 months prior to baseline
- Current cancer diagnosis
- History of solid organ or stem cell transplant
- Blood, plasma, or platelet transfusion within 120 days prior to enrollment
- Confirmed pregnancy at enrollment
- For non-IBD participants: prior history of any IBD
- Investigator judgment that participation is not suitable
- Under 16 years of age
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants who undergo routine care are observed and provide blood and stool samples at baseline, 3 months, and 12 months. Additional tissue biopsies are collected during standard care endoscopic assessments within 12 months.
3 visits for sample collection and endoscopic assessments as part of routine care
Trial Site Locations
Total: 1 location
1
University of Nottingham
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
Actively Recruiting
Research Team
G
Gordon Moran Professor
N
Nadia Frowd
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
6
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