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Hyperbaric Oxygen Therapy for Perianal Fistulizing Crohn's Disease Not Responsive or Intolerant to Conventional Care: HYPNOTIC Pilot Study

Study acronym: HYPNOTIC
StatusNot Yet Recruiting
PhasePhase 1/2
Started
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Record History

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  1. Lead sponsor: Ottawa Hospital Research Institute to University of British Columbiav3 Show 6 more changesShow less
    • Primary completion date: Jan 2026 to Sep 2027
    • Start date: Jan 2024 to Sep 2026
    • Enrollment target: 40 to 54
    • Study completion date: Mar 2026 to Mar 2028
    • Eligibility criteria revised
    • Collaborators expanded, about 3 words
  2. Primary endpoint revised
    • Secondary endpoint revised
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
This study aims to test a new treatment called hyperbaric oxygen therapy (HBOT) for a severe type of inflammatory bowel disease called perianal Crohn's disease (PCD). PCD causes painful perianal infections and chronic drainage from fistula tracts, and current treatments are only moderately effective and may not be suitable for all patients. HBOT is a safe and commonly used treatment for chronic non-healing wounds and other conditions. Previous studies have suggested that HBOT may help heal fistulas in PCD patients, but these studies were small and lacked controls.
Trial Details
NCT Number NCT06109961
Lead Sponsor University of British Columbia
Collaborators: The Ottawa Hospital
Conditions
(from sponsor)		 Inflammatory Bowel Disease (IBD), Crohn Disease
Related terms Crohn Disease, Inflammatory Bowel Diseases
Enrollment 54 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov