Hyperbaric Oxygen Therapy for Ulcerative Colitis (HBOT-UC)

This study is investigating if Hyperbaric Oxygen Therapy (HBOT) can help people hospitalized with moderate to severe ulcerative colitis (UC) flares. HBOT involves breathing 100% oxygen in a special chamber under increased pressure. Researchers want to see if HBOT can improve symptoms like rectal bleeding and frequent bowel movements, and help patients avoid needing stronger medications or surgery. You might be able to join if you are 18-85 years old, have UC, and are hospitalized for a flare. The study is looking for 126 participants. The current status of the study is unclear.

Study design: This is an interventional study comparing Hyperbaric Oxygen Therapy to a sham (inactive) treatment, with a planned enrollment of 126 participants.
What's involved: If in the active HBOT group, you would receive 90-minute HBOT sessions once a day for 5 days. If in the sham group, you would receive 90-minute sham sessions once a day for 5 days.
Compensation: Not stated in the trial record.
Follow-up: The primary outcome, clinical response, is measured at Day 5.

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Hyperbaric Oxygen Therapy for Ulcerative Colitis (HBOT-UC)

Recruiting

NAAges 18–85InterventionalTreatment

Northwestern University

~126 participants

Updated 2026-01-08 on ClinicalTrials.gov

What's tested:Hyperbaric Oxygen TherapySham Hyperbaric Air

At a glance

Recruiting sites

12 of 13 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Clinical response defined as complete resolution of rectal bleeding and improvement in stool frequency, without need for in-hospital biologics, small molecules, or colectomy by study day 5

Measured over Day 5

Conditions

Ulcerative Colitis

Where it's being run

13 sites across 10 states

Florida2

New York2

Pennsylvania2

Alabama1

California1

Illinois1

Kentucky1

Massachusetts1

Study leadership

Lauren Balmert Bonner, PhD · PRINCIPAL_INVESTIGATOR · Northwestern University

Who to contact

Yasmin Pina, BS

[email protected]

312-503-6459

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

Clinical response defined as complete resolution of rectal bleeding and improvement in stool frequency, without need for in-hospital biologics, small molecules, or colectomy by study day 5Day 5
Proportion of participants achieving clinical response as measured by complete resolution of rectal bleeding (Mayo rectal bleeding sub-score of 0) and improvement in stool frequency (at least 1 point reduction in Mayo stool frequency sub-score), without the need for in-hospital biologics, small molecules, or colectomy, by study day 5.

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