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Can pressurized oxygen heal Crohn's fistulas when drugs fail?

NCT ID NCT06109961

Disease control Sponsor: University of British Columbia Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This study tests whether hyperbaric oxygen therapy (HBOT) — breathing pure oxygen in a pressurized chamber — can help heal perianal fistulas in people with Crohn's disease who haven't improved with standard treatments. Participants will either receive HBOT or continue with conventional care, and researchers will measure how well fistulas close and how feasible the treatment is. The goal is to see if this safe, widely used therapy could become a new option for a painful condition that is often hard to treat.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Hyperbaric oxygen therapy (HBOT) — breathing 100% oxygen under increased pressure
What this could lead to
If effective, HBOT could offer a new, non-drug option to heal fistulas in Crohn's disease patients who haven't responded to standard treatments.
What could go wrong
This is an early pilot study with a small number of participants, so results may not be conclusive. HBOT requires multiple sessions and may not work for everyone, and there are risks like ear or sinus discomfort from pressure changes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 54 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Crohn disease inflammatory bowel disease perianal Crohn disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn disease Inflammatory bowel disease (IBD)

How to take part

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  1. The official record

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    Open the record ↗

  2. A doctor treating you

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