Hyperbaric Oxygen Therapy for Ulcerative Colitis (HBOT-UC)
Recruiting · NCT05987852 · Interventional (participants receive a specific treatment) · Lead sponsor: Northwestern University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
13 locations listed across 10 US states.
- University of Alabama Medicine - Birmingham, Alabama, United States
- University of Los Angeles Health - Los Angeles, California, United States
- University of Miami Health - Miami, Florida, United States
- Orlando Health - Orlando, Florida, United States
- Northwestern Medicine Lake Forest Hospital - Lake Forest, Illinois, United States
- University of Louisville - Louisville, Kentucky, United States
- Massachusetts General Hospital - Boston, Massachusetts, United States
- Mayo Clinic - Rochester, Minnesota, United States
- Dartmouth Hitchcock Medical Center - Lebanon, New Hampshire, United States
- Cornell University Medical Center - New York, New York, United States
- State University of New York Upstate Medical University - Syracuse, New York, United States
- Allegheny Health - Pittsburgh, Pennsylvania, United States
- University of Pittsburgh Medical Center - Pittsburgh, Pennsylvania, United States