NAZA - Nottingham/Astra ZenecA Prospective IBD Cohort Study
Observational · No treatment assigned · 1 site · University of Nottingham
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Gastro-Intestinal Disorder, Crohn Disease and Ulcerative Colitis. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 16 and older
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- 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…
Plus 2 more requirement(s). There are also 12 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 240 participants are expected to take part.
- Start date: 2022-12-12.
- Main results expected around 2026-12-31 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United Kingdom.
Main thing being measured
- The comparison of the IL-23/Th17 inflammatory axis between IBD and healthy control samples (Baseline, Month 3 and Month 12)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Gastro-Intestinal Disorder; Crohn Disease; Ulcerative Colitis; Inflammatory Bowel Diseases |
| Lead sponsor | University of Nottingham |
| Collaborators | Nottingham University Hospitals NHS Trust |
| Enrollment | 240 (estimated) |
| Start date | 2022-12-12 |
| Primary completion (est.) | 2026-12-31 |
| First posted | 2025-05-04 |
| Last updated | 2026-07-08 |
| Official title | NAZA - Nottingham/Astra ZenecA Prospective IBD Cohort Study |
| ClinicalTrials.gov ID | NCT06956703 |
Interventions
- None listed
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| University of Nottingham | Nottingham, Nottinghamshire | United Kingdom | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.