Regulation of Mucosal Healing in Inflammatory Bowel Disease

StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Primary endpoint(s) modified Show 7 more changesShow less
    • Results posted: Sep 30, 2026
    • Trial completed
    • Final enrollment: 26 participants (planned 60)
    • Primary completion date changed from estimate of Jun 1, 2026 to Aug 15, 2024
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints revised (2)
    • Site details revised
  2. Primary and study completion dates: May 1, 2025 to Jun 1, 2026v8
  3. Re-verified, no change to tracked fieldsv7
  4. Site contact updatedv6
  5. Collaborators expanded, about 10 wordsv5
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  1. Re-verified, no change to tracked fieldsv4
  2. Start date changed from estimate of Oct 20, 2020 to Apr 30, 2021v3
  3. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date: Aug 1, 2020 to Oct 20, 2020
    • Site details revised
    • Eligibility criteria shortened, about 2 words
    • Study description shortened, about 1 word
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT04504136
Lead Sponsor Terrence A Barrett
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions
(from sponsor)		 Inflammatory Bowel Diseases
Related terms Arthritis, Psoriatic, Arthritis, Rheumatoid, Colitis, Inflammatory Bowel Diseases, Ulcer, Wounds and Injuries
Enrollment 26 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov