Not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.
PSC Trial Watch
Crohn'sUCRecruiting

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

Some of the main requirements, copied from the record:

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

Main thing being measured

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

Official details

StatusRecruiting
PhaseObservational
Study typeObservational
ConditionsGastro-Intestinal Disorder; Crohn Disease; Ulcerative Colitis; Inflammatory Bowel Diseases
Lead sponsorUniversity of Nottingham
CollaboratorsNottingham University Hospitals NHS Trust
Enrollment240 (estimated)
Start date2022-12-12
Primary completion (est.)2026-12-31
First posted2025-05-04
Last updated2026-07-08
Official titleNAZA - Nottingham/Astra ZenecA Prospective IBD Cohort Study
ClinicalTrials.gov IDNCT06956703

Interventions

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)

SiteCityCountrySite status
University of NottinghamNottingham, NottinghamshireUnited KingdomRecruiting

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.