RecruitingNCT06956703

NAZA - Nottingham/Astra ZenecA Prospective IBD Cohort Study

Sponsor

University of Nottingham

Enrollment

240 participants

Start Date

Dec 12, 2022

Study Type

OBSERVATIONAL

Conditions

Inflammatory Bowel Diseases Crohn Disease Ulcerative Colitis Gastro-Intestinal Disorder

Summary

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

Min Age: 16 Years

Inclusion Criteria7

\. Provision of signed and dated, written informed consent before any study specific procedures
AND
a. 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
b. 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
c. 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 Criteria12

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
Participation in a clinical study with pharmacological intervention within 3 months prior to Baseline visit.
Current diagnosis of cancer
Having received a solid organ or stem cell transplant
Having received a transfusion of blood, plasma, or platelets within 120 days prior to enrolment
Confirmed pregnancy at time of enrolment
For non-IBD participants: A prior history of IBD (CD, UC, microscopic colitis, indeterminate colitis or IBD unspecified)
Clinical judgement by the investigator that the patient should not participate in the study
Under 16yrs of age