NAZA - Nottingham/Astra ZenecA Prospective IBD Cohort Study

NCT06956703 | Recruiting

• 1 other identifier: 22GA031
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastro-Intestinal Disorder; Crohn Disease; Ulcerative Colitis; Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• The comparison of the IL-23/Th17 inflammatory axis between IBD and healthy control samples

  Baseline, Month 3 and Month 12

Secondary Outcomes (2)

• Characterisation of IL-23/Th17 inflammatory axis within IBD biosamples stratified by prior biologic exposure

  Baseline, Month 3 and Month 12

• Comparison of mRNA sequencing readouts, characterisation of tissue and immune cell populations, characterisation of protein expression and characterisation of microbial species in the stool and tissue

  Baseline, Month 3 and Month 12

Study Arms (6)

Crohn's Disease - anti-TNFα therapy

Consultant will prescribe biologic dose, frequency and duration as normal standard of care

Crohn's Disease - ustekinumab

Consultant will prescribe biologic dose, frequency and duration as normal standard of care

Crohn's Disease - upadacitinib

Consultant will prescribe biologic dose, frequency and duration as normal standard of care

Ulcerative Colitis - anti-TNFα therapy

Consultant will prescribe biologic dose, frequency and duration as normal standard of care

Ulcerative Colitis - vedolizumab

Consultant will prescribe biologic dose, frequency and duration as normal standard of care

Control non-IBD

No biologic will be prescribed

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A cohort study in patients with moderate to severely active Crohn's Disease (CD) and Ulcerative Colitis (UC) who are switching to new targeted biologic therapy (with a different mode of action) - onto either anti-TNFα therapy or vedolizumab for UC or onto anti-TNFα therapy or ustekinumab or upadacitinib for CD and undergoing routine endoscopic assessments as part of normal clinical practice. We will also recruit participants without these conditions (controls) who are due for a lower GI colonoscopy as part of the UK national bowel cancer screening programme or on any hospital/ medical/ clinical screening list or any other appropriate list with no pathology found on examination.

You may qualify if:

• \. 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
• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nottingham: lead
• Nottingham University Hospitals NHS Trust: collaborator

Study Sites (1)

University of Nottingham

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Digestive System Diseases; Crohn Disease; Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Gordon Moran Professor

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gordon Moran Professor

CONTACT

0115 9249924; Gordon.Moran@nottingham.ac.uk

Nadia Frowd

CONTACT

nadia.frowd1@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 4, 2025
• Study Start: December 12, 2022
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: May 29, 2025

Record last verified: 2024-12

Locations

GB (1)