Oxygen therapy may help hospitalized colitis patients avoid surgery
NCT ID NCT05987852
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether breathing pure oxygen in a pressurized chamber (hyperbaric oxygen therapy) can help people hospitalized with moderate to severe ulcerative colitis flares. The goal is to see if this treatment can stop symptoms like rectal bleeding and frequent stools, and reduce the need for stronger medications or surgery. About 126 adults aged 18 to 85 will take part, receiving either real or sham oxygen sessions. The approach aims to improve oxygen levels in the gut to reduce inflammation.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 126 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Participants with known or newly diagnosed UC who require hospitalization for an acute moderate to severe flare * Age 18-85 * Able to fully participate in all aspects of the trial * Consented and able to receive first HBOT session within first 48 hours of initiation of intravenous steroids * Agreement to not participate in another trial for the duration of the active intervention period Exclusion Criteria: * Received hyperbaric oxygen therapy either as part of standard of care or through a clinical trial prior to enrollment * Complication requiring urgent surgical intervention * Requirement for new start of a biologic or small molecule during the hospitalization prior to randomization and/or anticipated requirement for rescue medical or surgical therapy within 48 hours of randomization * Toxic megacolon * Inability to receive intravenous steroids * Historically failed or been exposed to 4 or more classes of advanced therapeutic options * Known or suspected diagnosis of Crohn's colitis, indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, microscopic colitis or infectious colitis * Received any investigational drug within 30 days * Clinically significant cardiac, renal, neurological, endocrine, respiratory or hepatic impairment that increases the risk for HBOT toxicity * Women who are pregnant or nursing * Unwillingness to complete course of HBOT
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
12 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Allegheny Health
RECRUITINGPittsburgh, Pennsylvania, 15090, United States
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Cornell University Medical Center
ACTIVE_NOT_RECRUITINGNew York, New York, 10065, United States
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Dartmouth Hitchcock Medical Center
RECRUITINGLebanon, New Hampshire, 03756, United States
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Massachusetts General Hospital
RECRUITINGBoston, Massachusetts, 02114, United States
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Mayo Clinic
RECRUITINGRochester, Minnesota, 55905, United States
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Northwestern Medicine Lake Forest Hospital
RECRUITINGLake Forest, Illinois, 60045, United States
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Orlando Health
RECRUITINGOrlando, Florida, 32806, United States
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State University of New York Upstate Medical University
RECRUITINGSyracuse, New York, 13210, United States
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University of Alabama Medicine
RECRUITINGBirmingham, Alabama, 35233, United States
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University of Los Angeles Health
RECRUITINGLos Angeles, California, 90024, United States
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University of Louisville
RECRUITINGLouisville, Kentucky, 40202, United States
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University of Miami Health
RECRUITINGMiami, Florida, 33136, United States
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University of Pittsburgh Medical Center
RECRUITINGPittsburgh, Pennsylvania, 15213, United States
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- A breath test for gut disease? researchers hunt for invisible clues