Inflammatory Bowel Disease (IBD)Phase 1/2HYPNOTICNCT06109961
Hyperbaric Oxygen Therapy for Perianal Fistulizing Crohn's Disease Not Responsive or Intolerant to Conventional Care: HYPNOTIC Pilot Study
A Phase 1/2 study testing Oxygen Gas for Inhalation in people with Inflammatory Bowel Disease (IBD) and Crohn Disease, run by University of British Columbia.
Trial 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 infections and chronic drainage from fistula tracts, and current treatments are only moderately effective and may not be… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Inflammatory Bowel Disease (IBD), Crohn Disease
- What is being tested?
- Oxygen Gas for Inhalation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Mar 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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 times standard atmospheric pressure at sea level (2.0-2.5 ATA). This results in increased oxygen tension in plasma and promotes the diffusion of oxygen into tissue, which stimulates tissue restorative pathways that are essential for wound healing16. Hyperoxia also modulates the immune system by suppressing proinflammatory cytokines and promoting the production of anti-inflammatory cytokines. It also enhances the production of growth factors, mobilize stem cells, and stimulates anti-microbial pathways, all of which are believed to be central mechanisms involved in the repair of damaged tissue in IBD. The safety profile of HBOT is also excellent, with a reported adverse event incidence of 10 per 10,000. The most reported adverse event is middle ear barotrauma, which is minor and not life threatening.
There is emerging evidence that HBOT may be an effective treatment option for perianal Crohn's disease (PCD). To date, 10 observational studies with a total of 118 patients with PCD refractory to conventional therapy have assessed the effectiveness and safety of HBOT (McCurdy et al., IBDJ 2021). In this small number of patients, HBOT resulted in high rates of clinical response (75% [95% CI, 66%-83%; I2, 0]) and clinical remission (55% [95% CI, 44%-65%; I2, 61]) (Figure 1). Additionally, the HOT-TOPICs study, an open-label observational study demonstrated that HBOT was associated with radiologic improvement of fistula tracts as shown by a reduction in the modified Van Assche MRI score from 9.2 (95% CI, 7.3-11.2) to 7.3 (95% CI, 6.9-9.7). Despite these encouraging results, formal controlled clinical trials have not yet been conducted in patients with PCD to determine the true clinical impact of HBOT in this disease.
- Conditions
- Inflammatory Bowel Disease (IBD), Crohn Disease
- Being tested
- Oxygen Gas for Inhalation, Standard of care
- Keywords
- Perianal Crohn's disease (PCD), Hyperbaric oxygen therapy (HBOT), Tumor necrosis factor (TNF)
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen Gas for InhalationDrug
The active Hyperbaric Oxygen Therapy (HBOT) arm will receive 100% oxygen at 2.0-2.5 atmospheres (ATM).
Standard of careOther
Also called Conventional therapies
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Hyperbaric Oxygen Therapy | Experimental | The active Hyperbaric Oxygen Therapy (HBOT) arm will receive 100% oxygen at 2.0-2.5 atmospheres (ATM). Receives: Drug: Oxygen Gas for Inhalation |
| Standard of care treatment | Other | The 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. Tumor necrosis factor (TNF) antagonists are considered the first-line therapy for PCD, and clinical trial evidence supports their efficacy in achieving short-term fistula remission. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1 recruitment rate
Primary outcome for phase 1 is the rate of recruitment. Recruitment is defined as the number of randomized patients that receive at least one treatment (active HBOT or control) per year. After one year, recruitment of 20 patients or more (an average of 4 patients per site) will be considered acceptable to proceed to phase 2 without a requirement for modifications, recruitment of 10-20 patients will suggest minor modifications to the protocol are required and recruitment of less than 10 patients will suggest major modifications to the protocol are required prior to proceeding to phase 2.
Measured: 1 year
Secondary outcomes (1)
Phase 2 numbers of closure all external openings of fistula tracts
The primary outcome for phase 2 is the proportion of patients who achieve combined remission of perianal fistulizing Crohn's Disease at week 12 defined as closure of all external openings by finger compression test, and an absence of collections >2 cm confirmed by MRI assessment assessed at 8-12 weeks. MRI pelvis is the optimal outcome measure for measuring response to treatment as it has been shown to be the most accurate test for predicting long-term outcomes.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Disease (IBD)Studies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, multicenter, randomized open-label clinical trial and parallel registry.
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- The Ottawa Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06109961
- Sponsor's protocol ID
- H26-01477
- Acronym
- HYPNOTIC
- Status last verified
- Aug 2026
- First submitted
- 25 Oct 2023
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- HYPNOTIC / H26-01477
- Conditions
- Inflammatory Bowel Disease (IBD), Crohn Disease
- Keywords
- Perianal Crohn's disease (PCD), Hyperbaric oxygen therapy (HBOT), Tumor necrosis factor (TNF)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- The Ottawa Hospital
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 times standard atmospheric pressure at sea level (2.0-2.5 ATA). This results in increased oxygen tension in plasma and promotes the diffusion of oxygen into tissue, which stimulates tissue restorative pathways that are essential for wound healing16. Hyperoxia also modulates the immune system by suppressing proinflammatory cytokines and promoting the production of anti-inflammatory cytokines. It also enhances the production of growth factors, mobilize stem cells, and stimulates anti-microbial pathways, all of which are believed to be central mechanisms involved in the repair of damaged tissue in IBD. The safety profile of HBOT is also excellent, with a reported adverse event incidence of 10 per 10,000. The most reported adverse event is middle ear barotrauma, which is minor and not life threatening.
There is emerging evidence that HBOT may be an effective treatment option for perianal Crohn's disease (PCD). To date, 10 observational studies with a total of 118 patients with PCD refractory to conventional therapy have assessed the effectiveness and safety of HBOT (McCurdy et al., IBDJ 2021). In this small number of patients, HBOT resulted in high rates of clinical response (75% [95% CI, 66%-83%; I2, 0]) and clinical remission (55% [95% CI, 44%-65%; I2, 61]) (Figure 1). Additionally, the HOT-TOPICs study, an open-label observational study demonstrated that HBOT was associated with radiologic improvement of fistula tracts as shown by a reduction in the modified Van Assche MRI score from 9.2 (95% CI, 7.3-11.2) to 7.3 (95% CI, 6.9-9.7). Despite these encouraging results, formal controlled clinical trials have not yet been conducted in patients with PCD to determine the true clinical impact of HBOT in this disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective, multicenter, randomized open-label clinical trial and parallel registry.
| Arm | Type | Receives |
|---|---|---|
| Active Hyperbaric Oxygen Therapy | Experimental | Drug: Oxygen Gas for InhalationThe active Hyperbaric Oxygen Therapy (HBOT) arm will receive 100% oxygen at 2.0-2.5 atmospheres (ATM). |
| Standard of care treatment | Other | Other: Standard of careThe 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. Tumor necrosis factor (TNF) antagonists are considered the first-line therapy for PCD, and clinical trial evidence supports their efficacy in achieving short-term fistula remission. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxygen Gas for InhalationThe active Hyperbaric Oxygen Therapy (HBOT) arm will receive 100% oxygen at 2.0-2.5 atmospheres (ATM). | Drug | Active Hyperbaric Oxygen Therapy |
| Standard of careAlso: Conventional therapiesThe 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. | Other | Standard of care treatment |
Primary outcome
Phase 1 recruitment rate
Time frame: 1 year
Primary outcome for phase 1 is the rate of recruitment. Recruitment is defined as the number of randomized patients that receive at least one treatment (active HBOT or control) per year. After one year, recruitment of 20 patients or more (an average of 4 patients per site) will be considered acceptable to proceed to phase 2 without a requirement for modifications, recruitment of 10-20 patients will suggest minor modifications to the protocol are required and recruitment of less than 10 patients will suggest major modifications to the protocol are required prior to proceeding to phase 2.
1 secondary outcome
Phase 2 numbers of closure all external openings of fistula tracts
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Oxygen Gas for Inhalation in people with Inflammatory Bowel Disease (IBD) and Crohn Disease, run by University of British Columbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sherri Ferguson, MSc. (604-802-7069, sherri.ferguson@vch.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1 recruitment rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.