Status:
RECRUITING
Regulation of Mucosal Healing in Inflammatory Bowel Disease
Lead Sponsor:
Terrence A Barrett
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Inflammatory Bowel Diseases
Eligibility:
All Genders
18-90 years
Phase:
NA
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 ...
Detailed Description
Induction of mucosal healing in inflammatory bowel disease (IBD) is associated with reduced hospitalizations, surgeries, and reduced cancer risk. However, previous studies have shown that 54-69% of ul...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04504136
Start Date
April 30 2021
End Date
June 1 2026
Last Update
June 8 2025
Active Locations (1)
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1
University of Kentucky
Lexington, Kentucky, United States, 40536