Hyperbaric Oxygen Therapy for Perianal Fistulizing Crohn's Disease Not Responsive or Intolerant to Conventional Care: HYPNOTIC Pilot Study
Phase 1 / Phase 2 · Testing Oxygen Gas for Inhalation and Standard of care · Sites not listed yet · University of British Columbia
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Oxygen Gas for Inhalation (a drug) and Standard of care as a possible treatment. Condition(s) listed: Inflammatory Bowel Disease (IBD) and Crohn Disease.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 19 and older
- Any sex
Some of the main requirements, copied from the record:
- 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.
Plus 3 more requirement(s). There are also 7 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 54 participants are expected to take part.
- Start date: 2026-09 (planned).
- Main results expected around 2027-09 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Main thing being measured
- Phase 1 recruitment rate (1 year)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Phase 1 / Phase 2 |
| Study type | Interventional |
| Conditions | Inflammatory Bowel Disease (IBD); Crohn Disease |
| Lead sponsor | University of British Columbia |
| Collaborators | The Ottawa Hospital |
| Enrollment | 54 (estimated) |
| Start date | 2026-09 |
| Primary completion (est.) | 2027-09 |
| First posted | 2023-10-31 |
| Last updated | 2026-08-26 |
| Official title | Hyperbaric Oxygen Therapy for Perianal Fistulizing Crohn's Disease Not Responsive or Intolerant to Conventional Care: HYPNOTIC Pilot Study |
| ClinicalTrials.gov ID | NCT06109961 |
Interventions
- Oxygen Gas for Inhalation (Drug)
The active Hyperbaric Oxygen Therapy (HBOT) arm will receive 100% oxygen at 2.0-2.5 atmospheres (ATM). - Standard of care (Other)
The accepted standard of care for perianal Crohn's disease (PCD) involves conventional therapies such as immunosuppressive agents and biologics, which can be used to induce and maintain fistula remission.
Full eligibility criteria (from the record)
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Locations (0)
No sites listed yet. The official record has contact information.
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.