Regulation of Mucosal Healing in Inflammatory Bowel Disease

Who is this study for? Patients with rheumatoid or psoriatic arthritis and patients with inflammatory bowel disease
What treatments are being studied? Serial biopsy
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: t
View:

• Diagnosed ulcerative colitis or Crohn's disease

• Biologic failure or naive to biologic treatment

• Eligible to be treated with anti-TNF therapy

• Diagnosed rheumatoid or psoriatic arthritis

• Receiving anti-TNF antibody therapy at the time of enrollment

• Endoscopically unremarkable colonic mucosa

• Absence of inflammatory bowel disease

Locations
United States
Kentucky
University of Kentucky
RECRUITING
Lexington
Contact Information
Primary
Terrence A Barrett, MD
t.barrett@uky.edu
8593234887
Backup
Neeraj Kapur, PhD
neeraj.kapur@uky.edu
Time Frame
Start Date: 2021-04-30
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 60
Treatments
Experimental: Healthy Controls
Participants in this group will be healthy (not diagnosed with inflammatory bowel disease).
Experimental: Inflammatory Bowel Disease
Participants in this group will have been diagnosed with ulcerative colitis (UC) or Crohn's disease (CD) and have either failed treatment with biologics or be naive to biologic therapy.
Experimental: Rheumatoid/Psoriatic Arthritis
Participants in this group will have been diagnosed with rheumatoid (RA) or psoriatic arthritis (PsA) and will be receiving anti-TNF antibody therapy at the time of enrollment.
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Terrence A Barrett

This content was sourced from clinicaltrials.gov