NCT04504136 Regulation of Mucosal Healing in Inflammatory Bowel Disease
| NCT ID | NCT04504136 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Terrence A Barrett |
| Condition | Inflammatory Bowel Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2021-04-30 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2021-04-30 with a primary completion date of 2026-06-01.
⚠ 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 objective of the current study is to compare non-healing colonic ulcers in patients with inflammatory bowel disease (IBD) with iatrogenic colonic ulcers (biopsy sites) in healthy control patients and patients with rheumatoid or psoriatic arthritis. Patients will be biopsied at baseline and again at a follow-up visit in a "biopsy of the biopsy" approach. These biopsies will be used to reveal patterns about gene expression and mitochondrial function during ulcer healing.
Eligibility Criteria
Inclusion Criteria (Group 1): * Diagnosed ulcerative colitis or Crohn's disease * Biologic failure or naive to biologic treatment * Eligible to be treated with anti-TNF therapy Inclusion Criteria (Group 2): * Diagnosed rheumatoid or psoriatic arthritis * Receiving anti-TNF antibody therapy at the time of enrollment Inclusion Criteria (Group 3): * Endoscopically unremarkable colonic mucosa * Absence of inflammatory bowel disease Exclusion Criteria: * Classified in an anesthesia risk group, ASA Class =4 * History of bleeding diathesis or coagulopathy * Stroke or transient neurological attack with the last 6 months * Pregnant * Receiving anticoagulants or anti-platelet medications other than low-dose aspirin * Receiving steroid therapy or metformin * HIV positive * Incarceration * History of total proctocolectomy * History of system chemotherapy within 18 months * Uncontrolled intercurrent illness
Contact & Investigator
Terrence Barrett, MD
PRINCIPAL INVESTIGATOR
University of Kentucky
Frequently Asked Questions
Who can join the NCT04504136 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Inflammatory Bowel Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04504136 currently recruiting?
Yes, NCT04504136 is actively recruiting participants. Contact the research team at t.barrett@uky.edu for enrollment information.
Where is the NCT04504136 trial being conducted?
This trial is being conducted at Lexington, United States.
Who is sponsoring the NCT04504136 clinical trial?
NCT04504136 is sponsored by Terrence A Barrett. The principal investigator is Terrence Barrett, MD at University of Kentucky. The trial plans to enroll 60 participants.