Regulation of Mucosal Healing in Inflammatory Bowel Disease
2 other identifiers
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2020
CompletedFirst Posted
Study publicly available on registry
August 7, 2020
CompletedStudy Start
First participant enrolled
April 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
June 8, 2025
June 1, 2025
5.1 years
August 4, 2020
June 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Change in mitochondrial DNA copy number
Mitochondrial DNA copy number will be measured in epithelial cells collected from biopsies taken during the initial colonoscopy and at the follow-up colonoscopy.
35 days
Change in expression levels of cMyc
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.
35 days
Change in expression levels of PGC-1 alpha
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.
35 days
Change in expression levels of Ki67
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.
35 days
Number of visible ulcers
The number of visible ulcers will be assessed during the follow-up endoscopy for healthy patients and rheumatoid/psoriatic arthritis patients only.
1 day (at follow-up visit)
Secondary Outcomes (2)
Change in Mayo Endoscopic Score
35 days
Change in Segmental SES-CD Score
35 days
Other Outcomes (1)
Fecal calprotectin levels
35 days
Study Arms (3)
Healthy Controls
EXPERIMENTALParticipants in this group will be healthy (not diagnosed with inflammatory bowel disease).
Inflammatory Bowel Disease
EXPERIMENTALParticipants in this group will have been diagnosed with ulcerative colitis (UC) or Crohn's disease (CD) and have either failed treatment with biologics or be naive to biologic therapy.
Rheumatoid/Psoriatic Arthritis
EXPERIMENTALParticipants in this group will have been diagnosed with rheumatoid (RA) or psoriatic arthritis (PsA) and will be receiving anti-TNF antibody therapy at the time of enrollment.
Interventions
During the initial colonoscopy, 16-20 biopsies will be collected in addition to standard of care biopsies, and biopsy sites will be tattoed. Patients will return for a follow-up colonoscopy 4-35 days later. An additional 16-20 biopsies will be collected in a "biopsy of the biopsy" approach.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Kentucky
Lexington, Kentucky, 40536, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Terrence Barrett, MD
University of Kentucky
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 4, 2020
First Posted
August 7, 2020
Study Start
April 30, 2021
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
June 8, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share