Tests oxygen therapy in hospitalized people with ulcerative colitis flares
Tests hyperbaric oxygen therapy against a sham treatment in adults with severe colitis flares.
Plain-language title generated from the registry record
Registry title: Hyperbaric Oxygen Therapy for Ulcerative Colitis (HBOT-UC)
Key facts
- Where
- Birmingham, Boston, Lake Forest, Lebanon, Los Angeles, Louisville, Miami, New York, Orlando, Pittsburgh, Rochester, and Syracuse, United StatesSee the 13 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT05987852, who can take part
Where in United States
- University of Alabama MedicineBirmingham, United StatesTaking people
- Massachusetts General HospitalBoston, United StatesTaking people
- Northwestern Medicine Lake Forest HospitalLake Forest, United StatesTaking people
- Dartmouth Hitchcock Medical CenterLebanon, United StatesTaking people
- University of Los Angeles HealthLos Angeles, United StatesTaking people
- University of LouisvilleLouisville, United StatesTaking people
- University of Miami HealthMiami, United StatesTaking people
- Cornell University Medical CenterNew York, United StatesNo longer taking part
- Orlando HealthOrlando, United StatesTaking people
- Allegheny HealthPittsburgh, United StatesTaking people
- University of Pittsburgh Medical CenterPittsburgh, United StatesTaking people
- Mayo ClinicRochester, United StatesTaking people
- State University of New York Upstate Medical UniversitySyracuse, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Northwestern University
- Trial code
- NCT05987852
- Record updated
- 23 October 2026
- Original description
Chronic intestinal hypoxia and accompanying mucosal inflammation is a hallmark of ulcerative colitis (UC). Hyperbaric oxygen therapy (HBOT) involves breathing 100% oxygen under increased atmospheric pressure to increase tissue oxygenation. Two small prospective randomized controlled trials have demonstrated that the delivery of HBOT to UC patients hospitalized for acute moderate to severe flares results in improved remission rates and avoidance of in-hospital progression to biologics, small molecules, or colectomy. In this larger trial the study aims to confirm the treatment benefits of HBOT for hospitalized UC patients and study the immune-microbe mechanisms underpinning treatment response.Read full original descriptionShow less
Hyperbaric Oxygen Therapy for Ulcerative Colitis Patients Hospitalized for Moderate to Severe Flares: A Multi-Center, Randomized, Double-Blind, Sham-Controlled Trial
Chronic intestinal hypoxia and accompanying mucosal inflammation is a hallmark of ulcerative colitis (UC). Hyperbaric oxygen therapy (HBOT) involves breathing 100% oxygen under increased atmospheric pressure to increase tissue oxygenation. Two small prospective randomized controlled trials have demonstrated that the delivery of HBOT to UC patients hospitalized for acute moderate to severe flares results in improved remission rates and avoidance of in-hospital progression to biologics, small molecules, or colectomy. In this larger trial the study aims to confirm the treatment benefits of HBOT for hospitalized UC patients and study the immune-microbe mechanisms underpinning treatment response.
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; Inability to receive intravenous steroids; Received any investigational drug within 30 days; Known or suspected diagnosis of Crohn's colitis, indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, microscopic colitis or infectious colitis; Clinically significant cardiac, renal, neurological, endocrine, respiratory or hepatic impairment that increases the risk for HBOT toxicity; Toxic megacolon; Historically failed or been exposed to 4 or more classes of advanced therapeutic options; Women who are pregnant or nursing; Unwillingness to complete course of HBOT.