Regulation of Mucosal Healing in Inflammatory Bowel Disease
Recruiting · NCT04504136 · Interventional (participants receive a specific treatment) · Lead sponsor: Terrence A Barrett
View the official record on ClinicalTrials.gov →Interventions studied
Serial Biopsy
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.
Who can take part
Age range
18 Years to 90 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
4 locations listed across 1 US state.
- University of Kentucky - Lexington, Kentucky, United States
- University of Kentucky - Lexington, Kentucky, United States
- University of Kentucky - Lexington, Kentucky, United States
- University of Kentucky - Lexington, Kentucky, United States