Regulation of Mucosal Healing in Inflammatory Bowel Disease

Launched by TERRENCE A BARRETT · Aug 4, 2020

Keywords

ClinConnect Summary

This clinical trial is studying how different types of colon ulcers heal in patients with inflammatory bowel diseases (IBD), like ulcerative colitis and Crohn's disease, compared to healthy individuals and those with rheumatoid or psoriatic arthritis. Researchers want to understand the gene activity and energy function in cells during the healing process. Participants will undergo a procedure where small samples of tissue are taken from their colons, both at the start of the study and again later, to compare how healing happens in different groups.

To be eligible for this trial, you must be diagnosed with ulcerative colitis or Crohn's disease and either have not responded to certain treatments (like biologic therapies) or have never received them before. Alternatively, you could qualify if you have rheumatoid or psoriatic arthritis and are currently receiving a specific type of treatment called anti-TNF therapy. There is also a group for individuals without IBD, who have normal colon tissue. Participants can expect to have biopsies, which are small tissue samples, taken during the study. It's important to note that certain health conditions or treatments may prevent someone from joining the trial, so discussing your situation with a doctor would be necessary.

Gender

ALL

Eligibility 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