Comparing ulcer healing in inflammatory bowel disease and other conditions
Regulation of Mucosal Healing in Inflammatory Bowel Disease
This study is testing how well colonic ulcers heal in people with inflammatory bowel disease compared to healthy individuals and those with arthritis to better understand the healing process.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | University of Kentucky Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Lexington, Kentucky) |
| Trial ID | NCT04504136 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the healing of colonic ulcers in patients with inflammatory bowel disease (IBD) by comparing them to healthy controls and patients with rheumatoid or psoriatic arthritis. Participants will undergo biopsies at baseline and follow-up to analyze gene expression and mitochondrial function related to ulcer healing. The research focuses on understanding the mechanisms behind mucosal healing, which is crucial for reducing complications such as hospitalizations and surgeries in IBD patients. The study involves three groups: IBD patients treated with anti-TNF therapy, non-IBD patients on the same therapy, and healthy controls.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with ulcerative colitis or Crohn's disease who are either naive to or have failed biologic treatment.
Not a fit: Patients with conditions that significantly increase anesthesia risk or those with recent severe medical issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for healing ulcers in patients with inflammatory bowel disease.
How similar studies have performed: Other studies have shown promise in understanding ulcer healing mechanisms, but this specific comparative approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Lexington, Kentucky
- University of Kentucky — Lexington, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Terrence Barrett, MD — University of Kentucky
- Study coordinator: Terrence A Barrett, MD
- Email: t.barrett@uky.edu
- Phone: 8593234887
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.