NCT06956703 NAZA - Nottingham/Astra ZenecA Prospective IBD Cohort Study
| NCT ID | NCT06956703 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Nottingham |
| Condition | Gastro-Intestinal Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 240 participants |
| Start Date | 2022-12-12 |
| Primary Completion | 2027-02-28 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 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