Status:
NOT_YET_RECRUITING
Hyperbaric Oxygen Therapy for Perianal Fistulizing Crohn's Disease Not Responsive or Intolerant to Conventional Care: HYPNOTIC Pilot Study
Lead Sponsor:
Ottawa Hospital Research Institute
Conditions:
Inflammatory Bowel Disease (IBD)
Eligibility:
All Genders
17+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 infec...
Detailed Description
Hyperbaric oxygen therapy (HBOT) is an effective intervention for improving healing of chronic wounds. HBOT involves the delivery of 100% oxygen in a pressurized environment, typically two to three ti...
Eligibility Criteria
Inclusion
- Adults (\>17 years old)
- Diagnosis of Crohn's disease based on standard endoscopic, radiologic and/or histologic criteria.
- One or more perianal fistula tract connecting the rectum and the perianal skin. Patients must have active fistula drainage and/or a recurrent perianal abscess within the past month.
- Failure or intolerance of conventional therapy (imuran, methotrexate, anti-TNF therapies, vedolizumab and/or ustekinumab). Failure is defined as persistent perianal drainage or recurrent abscesses after a minimum of 3 months of therapy.
- Standard or care treatment has been stable (dose and treatment interval) for at least 3 months.
- Able to provide written consent to participate
Exclusion
- Fistulas not believed to be due to Crohn's disease (examples include, obstetrical complications, tuberculosis, anorectal cancer or diverticular fistula).
- Rectovaginal fistulas.
- Undrained perianal abscesses on pelvic MRI exams (abscesses will require successful drainage by an exam under anaesthesia with or without seton prior to study inclusion).
- Surgical procedure such as an advancement flap, fistula plug, fistula glue or ligation of intersphincteric fistula tract (LIFT) procedure within the past 6 months.
- Diverting ostomies or ileal pouch anal anastomosis.
- Current or planned pregnancy or lactation during the study treatment period.
- Contraindications to HBOT (claustrophobia, incompatible implanted medical device, and other conditions) based on the discretion of our HBOT clinicians.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06109961
Start Date
January 1 2024
End Date
March 1 2026
Last Update
November 7 2023
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