NAZA - Nottingham/Astra ZenecA Prospective IBD Cohort Study

Launched by UNIVERSITY OF NOTTINGHAM · Apr 24, 2025

Keywords

ClinConnect Summary

The NAZA trial is a research study that aims to understand the differences in inflammation markers between people with inflammatory bowel diseases (IBD) like Crohn's disease and ulcerative colitis, and healthy individuals without these conditions. By comparing these markers, the study hopes to learn more about how IBD affects the body and how it differs from those who do not have these diseases.

To participate in this study, you need to be at least 16 years old and either have active Crohn's disease or ulcerative colitis, or be a healthy individual undergoing a lower GI colonoscopy. Participants will need to provide signed consent and will be carefully monitored during the study. This is a great opportunity for those affected by IBD to contribute to valuable research that could help improve understanding and treatment in the future. If you have any questions or think you might be eligible, please reach out for more information!

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Provision of signed and dated, written informed consent before any study specific procedures
• • AND
• • 2a. Patients of at least 16 years of age with active Crohn's disease defined as: CRP \> = 5 mg/L OR FCP \> = 250 μg/g OR Visible ulcerations on ileocolonoscopy with a total SES-CD \> = 7, or \> = 4 if disease is confined to the terminal ileum OR visable active disease on cross-sectional imaging. Are switching to a new mechanism of action (MOA) onto anti-TNF therapy or ustekinumab or upadacitinib
• • OR
• • 2b. Patients of at least 16 years (no upper age limit) with active UC defined as: CRP \> = 5 mg/L OR FCP \> = 250 μg/g OR Mayo endoscopy subscore \> = 2. Are switching to a new mechanism of action (MOA) onto either anti-TNFα therapy or vedolizumab
• • OR
• • 2c. Non-IBD participants who are attending for a lower GI colonoscopy at any participating site. On any hospital/ medical/ clinical screening list or any other appropriate list with no pathology found on examination.
• Exclusion Criteria:
• • 1. Inability to give informed consent
• • 2. Any positive result from previous screening for serum hepatitis B surface antigen, hepatitis C or human immunodeficiency virus (HIV)
• • 3. An ongoing infection requiring treatment
• • 4. Clinical evidence of active COVID infection and/or evidence of active COVID determined by local standard care procedures
• • 5. Participation in a clinical study with pharmacological intervention within 3 months prior to Baseline visit.
• • 6. Current diagnosis of cancer
• • 7. Having received a solid organ or stem cell transplant
• • 8. Having received a transfusion of blood, plasma, or platelets within 120 days prior to enrolment
• • 9. Confirmed pregnancy at time of enrolment
• • 10. For non-IBD participants: A prior history of IBD (CD, UC, microscopic colitis, indeterminate colitis or IBD unspecified)
• • 11. Clinical judgement by the investigator that the patient should not participate in the study
• • 12. Under 16yrs of age