Status:
RECRUITING
Hyperbaric Oxygen Therapy for Ulcerative Colitis (HBOT-UC)
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
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 p...
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
Key Trial Info
Start Date :
January 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT05987852
Start Date
January 9 2024
End Date
September 1 2027
Last Update
January 8 2026
Active Locations (13)
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1
University of Alabama Medicine
Birmingham, Alabama, United States, 35233
2
University of Los Angeles Health
Los Angeles, California, United States, 90024
3
University of Miami Health
Miami, Florida, United States, 33136
4
Orlando Health
Orlando, Florida, United States, 32806