NCT05987852Recruiting
Hyperbaric Oxygen Therapy for Ulcerative Colitis (HBOT-UC)
Hyperbaric Oxygen Therapy for Ulcerative Colitis Patients Hospitalized for Moderate to Severe Flares: A Multi-Center, Randomized, Double-Blind, Sham-Controlled Trial
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 126 (estimated)
- First submitted
- 1 Aug 2023
- Start date
- 9 Jan 2024
- Primary completion date
- 1 Sept 2027
- Lead sponsor
- Northwestern University
- Diseases
- Ulcerative colitis
- NCT number
- NCT05987852
What you commit to
- Study type: Interventional
- Planned participants: 126
- From 9 Jan 2024 to the primary completion date, 1 Sept 2027
- 13 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alabama Medicine Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Northwestern Medicine Lake Forest Hospital Coordinator of this site? Confirm its status | Lake Forest | United States | Recruiting |
| Dartmouth Hitchcock Medical Center Coordinator of this site? Confirm its status | Lebanon | United States | Recruiting |
| University of Los Angeles Health Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| University of Louisville Coordinator of this site? Confirm its status | Louisville | United States | Recruiting |
| University of Miami Health Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Cornell University Medical Center Coordinator of this site? Confirm its status | New York | United States | Active, not recruiting |
| Orlando Health Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
| Allegheny Health Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| University of Pittsburgh Medical Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| State University of New York Upstate Medical University Coordinator of this site? Confirm its status | Syracuse | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.