Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
Healthy Volunteers
NCT04504136

Regulation of Mucosal Healing in Inflammatory Bowel Disease

Led by Terrence A Barrett · Updated on 2025-06-08

60

Participants Needed

1

Research Sites

265 weeks

Total Duration

On this page

Sponsors

T

Terrence A Barrett

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

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.

CONDITIONS

Official Title

Regulation of Mucosal Healing in Inflammatory Bowel Disease

Who Can Participate

Age: 18Years - 90Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed ulcerative colitis or Crohn's disease for Group 1
  • Biologic failure or naive to biologic treatment for Group 1
  • Eligible to be treated with anti-TNF therapy for Group 1
  • Diagnosed rheumatoid or psoriatic arthritis for Group 2
  • Receiving anti-TNF antibody therapy at enrollment for Group 2
  • Endoscopically unremarkable colonic mucosa for Group 3
  • No inflammatory bowel disease for Group 3
Not Eligible

You will not qualify if you...

  • Classified in anesthesia risk group ASA Class 4
  • History of bleeding diathesis or coagulopathy
  • Stroke or transient neurological attack within 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 systemic chemotherapy within 18 months
  • Uncontrolled intercurrent illness

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Kentucky

Lexington, Kentucky, United States, 40536

Actively Recruiting

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Research Team

T

Terrence A Barrett, MD

CONTACT

N

Neeraj Kapur, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

3

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