Regulation of Mucosal Healing in Inflammatory Bowel Disease

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Terrence A Barrett
Study ID
NCT04504136
Status
Recruiting
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Conditions

  • Inflammatory Bowel Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Accepted

Interventions

  • Serial Biopsy — PROCEDURE
    During the initial colonoscopy, 16-20 biopsies will be collected in addition to standard of care biopsies, and biopsy sites will be tattoed. Patients will return for a follow-up colonoscopy 4-35 days later. An additional 16-20 biopsies will be collected in a "biopsy of the biopsy" approach.

Study Details

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.

Key Dates

Start date
Apr 30, 2021
Status verified
Jun 2025
Primary completion
Jun 1, 2026
Completion
Jun 1, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • 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.

Primary Outcome Measure

Change in mitochondrial DNA copy number [ Time Frame: 35 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of KentuckyLexingtonKentucky40536
Syed Adeel Hassan, MBBS/MD
[email protected]
312-340-4925

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By research site
University of Kentucky· Lexington, KY

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