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Completed
NCT04504136
Regulation of Mucosal Healing in Inflammatory Bowel Disease
Conditions: Inflammatory Bowel Diseases
Sex: All
Ages: 18 Years – 90 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 26
Sponsor: Terrence A Barrett
Location: University of Kentucky Lexington Kentucky
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
Source: ClinicalTrials.gov (NCT04504136). StuddyBuddy aggregates publicly available trial information.