Actively Recruiting
Hyperbaric Oxygen Therapy for Ulcerative Colitis (HBOT-UC)
Led by Northwestern University · Updated on 2026-01-08
126
Participants Needed
13
Research Sites
190 weeks
Total Duration
On this page
Sponsors
N
Northwestern University
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Hyperbaric Oxygen Therapy for Ulcerative Colitis (HBOT-UC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with known or newly diagnosed ulcerative colitis who require hospitalization for an acute moderate to severe flare
- Age between 18 and 85 years
- Able to fully participate in all aspects of the trial
- Consented and able to receive first hyperbaric oxygen therapy session within 48 hours of starting intravenous steroids
- Agree not to participate in another trial during the active intervention period
You will not qualify if you...
- Prior receipt of hyperbaric oxygen therapy as standard care or in a clinical trial
- Presence of complications requiring urgent surgery
- Need to start biologic or small molecule treatments before randomization or likely need for rescue therapy within 48 hours after randomization
- Toxic megacolon
- Inability to receive intravenous steroids
- History of failure or exposure to 4 or more classes of advanced therapies
- Diagnosis or suspicion of Crohn's colitis, indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease with colitis, microscopic colitis, or infectious colitis
- Use of any investigational drug within 30 days
- Significant heart, kidney, nervous system, endocrine, lung, or liver problems increasing risk of HBOT toxicity
- Pregnancy or nursing
- Unwillingness to complete the HBOT course
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
University of Alabama Medicine
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
University of Los Angeles Health
Los Angeles, California, United States, 90024
Actively Recruiting
3
University of Miami Health
Miami, Florida, United States, 33136
Actively Recruiting
4
Orlando Health
Orlando, Florida, United States, 32806
Actively Recruiting
5
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, United States, 60045
Actively Recruiting
6
University of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
7
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
8
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
9
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
10
Cornell University Medical Center
New York, New York, United States, 10065
Active, Not Recruiting
11
State University of New York Upstate Medical University
Syracuse, New York, United States, 13210
Actively Recruiting
12
Allegheny Health
Pittsburgh, Pennsylvania, United States, 15090
Actively Recruiting
13
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
Y
Yasmin Pina, BS
CONTACT
M
Mary Beth Tull, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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