Regulation of Mucosal Healing in Inflammatory Bowel Disease

Inflammatory Bowel Diseases Clinical Trial

Official title: Regulation of Mucosal Healing in Inflammatory Bowel Disease

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

Induction of mucosal healing in inflammatory bowel disease (IBD) is associated with reduced hospitalizations, surgeries, and reduced cancer risk. However, previous studies have shown that 54-69% of ulcerative colitis (UC) patients fail to heal ulcers after several weeks of treatment, and roughly half do not maintain remission at one year. The single most important factor in preventing severe medical consequences, like colon removal surgery or cancer, is treatment to completely heal the top layer of the intestine as quickly as possible. Healing is a complex process and the dysfunction observed in colitis can only be fully understood by comparison to healing in non-IBD patients.

This is a prospective trial involving three groups of patients: 1) IBD patients with active disease, newly treated with anti-TNF therapy (biologic failure or naïve); 2) non-IBD patients with rheumatoid/psoriatic arthritis who are receiving anti-TNF therapy, and 3) healthy control patients. Biopsies will be collected at baseline during standard of care endoscopy and at a follow-up research endoscopy.

This study will probe mechanisms of ulcer healing by analyzing gene expression patterns and mitochondrial function. ;

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

• NCT number: NCT04504136
• Study type: Interventional
• Source: University of Kentucky
• Contact: Syed Adeel Hassan, MBBS/MD
• Phone: 312-340-4925
• Email: syed.hassan@uky.edu
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2021
• Completion date: May 1, 2025