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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DEVICE

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.

OTHER

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.

Locations (13)

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