Observational study comparing inflammatory markers in IBD and non-IBD participants

NAZA - Nottingham/Astra ZenecA Prospective IBD Cohort Study

This study is trying to see how inflammation levels in people with Crohn's Disease and Ulcerative Colitis compare to those without these conditions when they start new treatments.

Quick facts

• Study type: Observational
• Enrollment: 240 (estimated)
• Ages: 16 Years and up
• Sex: All
• Sponsor: University of Nottingham (Academic / other)
• Drugs / interventions: ustekinumab, vedolizumab, upadacitinib
• Locations: 1 site (Nottingham, Nottinghamshire)
• Trial ID: NCT06956703 on ClinicalTrials.gov

What this trial studies

This observational cohort study aims to compare inflammatory markers between patients with moderate to severely active Crohn's Disease and Ulcerative Colitis who are switching to new targeted biologic therapies and non-IBD control participants. Participants will provide blood and stool samples at three time points, along with tissue biopsies during routine endoscopic assessments. The study seeks to identify observable traits and molecular variability that may correlate with clinical responses to treatment. The findings could enhance the understanding of Inflammatory Bowel Diseases and inform better treatment strategies.

Who should consider this trial

Good fit: Ideal candidates include patients aged 16 and older with active Crohn's Disease or Ulcerative Colitis who are switching to new biologic therapies, as well as non-IBD participants undergoing routine colonoscopy.

Not a fit: Patients with stable IBD who are not switching therapies or those with other gastrointestinal disorders unrelated to IBD may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment approaches and better prediction of disease course for patients with Inflammatory Bowel Diseases.

How similar studies have performed: While this study employs a comparative approach, similar studies have shown promise in understanding inflammatory markers in IBD, suggesting potential for success.

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 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

Where this trial is running

Nottingham, Nottinghamshire

• University of Nottingham — Nottingham, Nottinghamshire, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Gordon Moran Professor — University of Nottingham
• Study coordinator: Gordon Moran Professor

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