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NCT06109961Not yet recruitingPhase 1/2

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

Source: ClinicalTrials.gov · Last updated 26 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
54 (estimated)
First submitted
25 Oct 2023
Start date
Sept 2026
Primary completion date
Sept 2027
Lead sponsor
University of British Columbia
NCT number
NCT06109961

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 54
  • From Sept 2026 to the primary completion date, Sept 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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).

Other illness

  • Fistulas not believed to be due to Crohn's disease (examples include, obstetrical complications, tuberculosis, anorectal cancer or diverticular fistula).
  • Surgical procedure such as an advancement flap, fistula plug, fistula glue or ligation of intersphincteric fistula tract (LIFT) procedure within the past 6 months.
  • Contraindications to HBOT (claustrophobia, incompatible implanted medical device, and other conditions) based on the discretion of our HBOT clinicians.

Other

  • Rectovaginal fistulas.
  • Diverting ostomies or ileal pouch anal anastomosis.
  • Current or planned pregnancy or lactation during the study treatment period.

Who the study is looking for

  • Adults (\>19 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

Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.