Actively Recruiting

Age: 16Years +
All Genders
Healthy Volunteers
NCT06956703

NAZA - Nottingham/Astra ZenecA Prospective IBD Cohort Study

Led by University of Nottingham · Updated on 2025-05-29

240

Participants Needed

1

Research Sites

219 weeks

Total Duration

On this page

Sponsors

U

University of Nottingham

Lead Sponsor

N

Nottingham University Hospitals NHS Trust

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

NAZA - Nottingham/Astra ZenecA Prospective IBD Cohort Study

Who Can Participate

Age: 16Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed and dated informed consent before any study procedures
  • Age 16 years or older
  • For Crohn's disease patients: active disease defined by CRP ≥ 5 mg/L, FCP ≥ 250 µg/g, visible ulcerations with SES-CD ≥ 7 (or ≥ 4 if limited to terminal ileum), or active disease on imaging, and switching to anti-TNF therapy, ustekinumab, or upadacitinib
  • For Ulcerative Colitis patients: active disease defined by CRP ≥ 5 mg/L, FCP ≥ 250 µg/g, or Mayo endoscopy subscore ≥ 2, and switching to anti-TNF alpha therapy or vedolizumab
  • Non-IBD participants attending for lower GI colonoscopy with no pathology found on examination
Not Eligible

You will not qualify if you...

  • Unable to give informed consent
  • Positive screening for hepatitis B surface antigen, hepatitis C, or HIV
  • Ongoing infection requiring treatment
  • Active COVID infection by clinical or standard care evidence
  • Participation in a pharmacological clinical study within 3 months prior to baseline
  • Current cancer diagnosis
  • History of solid organ or stem cell transplant
  • Blood, plasma, or platelet transfusion within 120 days before enrollment
  • Confirmed pregnancy at enrollment
  • For non-IBD participants: prior history of any form of IBD
  • Investigator judgment that participation is not appropriate
  • Under 16 years of age

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Nottingham

Nottingham, Nottinghamshire, United Kingdom, NG7 2UH

Actively Recruiting

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Research Team

G

Gordon Moran Professor

CONTACT

N

Nadia Frowd

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

6

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