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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Regulation of Mucosal Healing in Inflammatory Bowel Disease
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Terrence Barrett, MD · PRINCIPAL_INVESTIGATOR · University of Kentucky
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- 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.