Recruiting

Observational Study

Sponsor:

Terrence A Barrett

Code:

NCT04504136

Conditions

Inflammatory Bowel Diseases

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Serial Biopsy

Study Details

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 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.

Conditions

Inflammatory Bowel Diseases

Study ID

NCT04504136

Start date

Apr 30, 2021

Status verified date

Jun, 2025

Completion date

Jun 1, 2026

Anticipated

Primary completion date

Jun 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

Serial Biopsy

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.

Primary outcome measure

  • Change in mitochondrial DNA copy number [ Time Frame: 35 days ]
  • Change in expression levels of cMyc [ Time Frame: 35 days ]
  • Change in expression levels of PGC-1 alpha [ Time Frame: 35 days ]
  • Change in expression levels of Ki67 [ Time Frame: 35 days ]
  • Number of visible ulcers [ Time Frame: 1 day (at follow-up visit) ]

Central Contacts and Locations

Central contacts

Terrence A Barrett, MD

8593234887t.barrett@uky.edu

Neeraj Kapur, PhD

neeraj.kapur@uky.edu

Locations

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Syed Adeel Hassan, MBBS/MD

312-340-4925syed.hassan@uky.edu

More Information

Sponsor

Terrence A Barrett

Last update posted

Jun 8, 2025

Last verified

Jun, 2025

Keywords

  • mucosal
  • rheumatoid arthritis
  • psoriatic arthritis
  • ulcer
  • colitis
  • Crohn's
  • mitochondria
  • biopsy
  • wound
  • biologic
  • anti-TNF

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Terrence A Barrett on 2025-06-08.