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NCT04504136Completed

Regulation of Mucosal Healing in Inflammatory Bowel Disease

Source: ClinicalTrials.gov · Last updated 30 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
26 (actual)
First submitted
4 Aug 2020
Start date
30 Apr 2021
Primary completion date
15 Aug 2024
Lead sponsor
Terrence A Barrett
NCT number
NCT04504136

What you commit to

  • Study type: Interventional
  • Participants enrolled: 26
  • From 30 Apr 2021 to the primary completion date, 15 Aug 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Receiving steroid therapy or metformin

Other illness

  • History of bleeding diathesis or coagulopathy
  • Stroke or transient neurological attack with the last 6 months
  • HIV positive
  • History of total proctocolectomy
  • History of system chemotherapy within 18 months
  • Uncontrolled intercurrent illness

Lab values

  • Receiving anticoagulants or anti-platelet medications other than low-dose aspirin

Other

  • Classified in an anesthesia risk group, ASA Class =4
  • Pregnant
  • Incarceration

Who the study is looking for

  • 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

Age in the registry: 18 years to 90 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Kentucky
Coordinator of this site? Confirm its status
LexingtonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.