NCT06956703 NAZA - Nottingham/Astra ZenecA Prospective IBD Cohort Study
| NCT ID | NCT06956703 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Nottingham |
| Condition | Gastro-Intestinal Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 240 participants |
| Start Date | 2022-12-12 |
| Primary Completion | 2027-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 240 participants in total. It began in 2022-12-12 with a primary completion date of 2027-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Gordon Moran Professor
PRINCIPAL INVESTIGATOR
University of Nottingham
Frequently Asked Questions
Who can join the NCT06956703 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Gastro-Intestinal Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06956703 currently recruiting?
Yes, NCT06956703 is actively recruiting participants. Contact the research team at Gordon.Moran@nottingham.ac.uk for enrollment information.
Where is the NCT06956703 trial being conducted?
This trial is being conducted at Nottingham, United Kingdom.
Who is sponsoring the NCT06956703 clinical trial?
NCT06956703 is sponsored by University of Nottingham. The principal investigator is Gordon Moran Professor at University of Nottingham. The trial plans to enroll 240 participants.