Study on Mucosal Healing in Inflammatory Bowel Disease

This study aims to understand how ulcers heal in people with inflammatory bowel disease (IBD) compared to those without IBD. Researchers will compare non-healing ulcers in IBD patients with healing biopsy sites in healthy individuals and patients with rheumatoid or psoriatic arthritis. You may be eligible if you have ulcerative colitis or Crohn's disease and are starting anti-TNF therapy, or if you have rheumatoid or psoriatic arthritis and are already on anti-TNF therapy, or if you are a healthy control. The study involves taking biopsies during colonoscopies to look at gene expression and mitochondrial function, hoping to find patterns related to ulcer healing. The goal is to see changes in mitochondrial DNA and specific gene expression levels after about 35 days. The current recruitment status is unclear, and the study plans to enroll 60 participants.

Study design
This is an interventional study involving three groups of participants. It is not specified if it is randomized or blinded, but it aims to enroll 60 participants.
What's involved
You would undergo an initial colonoscopy where 16-20 extra biopsies are taken, and the sites are marked. You would then return for a follow-up colonoscopy 4-35 days later for another 16-20 biopsies from the same sites.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 35 days, which is when the primary endpoints are measured.

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NCT04504136

Regulation of Mucosal Healing in Inflammatory Bowel Disease

Recruiting
NAAges 18–90InterventionalBasic science
Terrence A Barrett
~60 participants
Updated 2025-06-08 on ClinicalTrials.gov
What's tested:Serial Biopsy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in mitochondrial DNA copy number
Measured over 35 days
+4 more outcomes measured
Inflammatory Bowel Diseases
1 sites across 1 states
Kentucky1
  • Terrence Barrett, MD · PRINCIPAL_INVESTIGATOR · University of Kentucky

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Eligibility criteria

Inclusion

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

Exclusion

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
  • Change in mitochondrial DNA copy number35 days

    Mitochondrial DNA copy number will be measured in epithelial cells collected from biopsies taken during the initial colonoscopy and at the follow-up colonoscopy.

  • Change in expression levels of cMyc35 days

    Relative expression of cMyc (mRNA) will be measured in epithelial cells collected from biopsies taken during the initial colonoscopy and at the follow-up colonoscopy.

  • Change in expression levels of PGC-1 alpha35 days

    Relative expression of PGC-1 alpha (mRNA) will be measured in epithelial cells collected from biopsies taken during the initial colonoscopy and at the follow-up colonoscopy.

  • Change in expression levels of Ki6735 days

    Relative expression of Ki67 alpha (mRNA) will be measured in epithelial cells collected from biopsies taken during the initial colonoscopy and at the follow-up colonoscopy.

  • Number of visible ulcers1 day (at follow-up visit)

    The number of visible ulcers will be assessed during the follow-up endoscopy for healthy patients and rheumatoid/psoriatic arthritis patients only.