Hyperbaric Oxygen Therapy for Ulcerative Colitis Patients Hospitalized for Moderate to Severe Flares: A Multi-Center, Randomized, Double-Blind, Sham-Controlled Trial
Status: Recruiting
Location: See all (13) locations...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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 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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• 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
Locations
United States
Alabama
University of Alabama Medicine
RECRUITING
Birmingham
California
University of Los Angeles Health
RECRUITING
Los Angeles
Florida
University of Miami Health
RECRUITING
Miami
Orlando Health
RECRUITING
Orlando
Illinois
Northwestern Medicine Lake Forest Hospital
RECRUITING
Lake Forest
Kentucky
University of Louisville
RECRUITING
Louisville
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Minnesota
Mayo Clinic
RECRUITING
Rochester
New Hampshire
Dartmouth Hitchcock Medical Center
RECRUITING
Lebanon
New York
Cornell University Medical Center
RECRUITING
New York
State University of New York Upstate Medical University
RECRUITING
Syracuse
Pennsylvania
Allegheny Health
RECRUITING
Pittsburgh
University of Pittsburgh Medical Center
RECRUITING
Pittsburgh
Contact Information
Primary
Yasmin Pina, BS
yasmin.pina@northwestern.edu
312-503-6459
Backup
Mary Beth Tull, MS
mary.tull@northwestern.edu
312-503-4746
Time Frame
Start Date:2024-01-09
Estimated Completion Date:2027-09-01
Participants
Target number of participants:126
Treatments
Experimental: Hyperbaric Oxygen Therapy
Participants enrolled in the active intervention group receiving HBOT will undergo compression to 2.4 Atmospheres Absolute (ATA; 100% O2) for 90 minutes with two 5-10 minute air breaks (breathing room air at the 2.4 ATA) during the session. This is done once a day for 5 days.
Sham_comparator: Sham Hyperbaric Air
This control arm will undergo compression to 1.34 ATA for monoplace chambers and 2.4 ATA for multiplace chambers for the full 90-minute session but 21% oxygen instead of 100% oxygen being administered. These participants will also have two 5-10 minute air breaks to mimic the treatment protocol. Multiplace sham sessions will have modified air breaks to avoid decompression sickness. This will happen once a day for 5 days.