ClinicalTrials.gov
Cure8 trial brief
Why This Matters
Understanding why some IBD ulcers fail to heal could help researchers develop better treatments or biomarkers to predict healing, which matters because mucosal healing reduces hospitalizations, surgeries, and cancer risk.
This trial uses paired biopsies and molecular measures to compare healing in IBD patients versus non‑IBD controls and patients on anti‑TNF therapy, a design that may reveal disease‑specific healing defects.
Who Should Pay Attention
Researchers studying mucosal healing, mitochondrial biology, or biomarkers; clinicians interested in mechanisms of non‑healing IBD ulcers; patients on or considering anti‑TNF therapy who follow research updates.
Study Snapshot
Story typeClinical Reference
Trial phaseNA
Enrollment26 participants
Study statusCompleted
Source depthTrial registry record
What To Know
This ClinicalTrials.gov record describes a completed interventional study that compared healing of colonic ulcers in three groups: IBD patients (UC or Crohn’s) starting or failing anti‑TNF therapy, patients with rheumatoid or psoriatic arthritis who are on anti‑TNF therapy, and healthy controls.
Participants underwent an initial colonoscopy with multiple biopsies (sites tattooed) and a follow-up colonoscopy 4–35 days later to collect paired biopsies (“biopsy of the biopsy”). The study measured mitochondrial DNA:nuclear DNA ratio and expression of genes/proteins linked to healing (cMyc, PGC‑1α, Ki67) and counted visible ulcers.
The trial is focused on molecular and cellular mechanisms of mucosal healing — gene expression and mitochondrial function — rather than testing a clinical treatment effect. Results are not presented in this record; the listing is a trial registry entry (COMPLETED) with planned enrollment of ~26 at the University of Kentucky.
If you’re looking for clinical implications, this study aims to identify biological differences in ulcer healing that could eventually inform treatments or biomarkers, but the registry entry itself does not report outcomes or practice-changing findings.
Keep In Mind
This is a registered interventional trial record (ClinicalTrials.gov) marked COMPLETED; the registry lists planned outcomes and methods but does not include published results in the provided text. The sample size is small (~26) and the follow‑up interval is short (4–35 days), so findings would be exploratory and require replication. SummaryConfidence: high
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorTerrence A Barrett
Trial IDNCT04504136
Study typeInterventional
Trial phaseNA
Enrollment26 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedSep 30, 2026, 12:00 AM
Content availableTrial registry record
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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