Actively Recruiting
Regulation of Mucosal Healing in Inflammatory Bowel Disease
Led by Terrence A Barrett · Updated on 2025-06-08
60
Participants Needed
1
Research Sites
265 weeks
Total Duration
On this page
Sponsors
T
Terrence A Barrett
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Regulation of Mucosal Healing in Inflammatory Bowel Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed ulcerative colitis or Crohn's disease for Group 1
- Biologic failure or naive to biologic treatment for Group 1
- Eligible to be treated with anti-TNF therapy for Group 1
- Diagnosed rheumatoid or psoriatic arthritis for Group 2
- Receiving anti-TNF antibody therapy at enrollment for Group 2
- Endoscopically unremarkable colonic mucosa for Group 3
- No inflammatory bowel disease for Group 3
You will not qualify if you...
- Classified in anesthesia risk group ASA Class 4
- History of bleeding diathesis or coagulopathy
- Stroke or transient neurological attack within 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 systemic chemotherapy within 18 months
- Uncontrolled intercurrent illness
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Kentucky
Lexington, Kentucky, United States, 40536
Actively Recruiting
Research Team
T
Terrence A Barrett, MD
CONTACT
N
Neeraj Kapur, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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