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NCT05987852NARecruiting

Hyperbaric Oxygen Therapy for Ulcerative Colitis (HBOT-UC)

Northwestern University

Start Date

1/9/2024

Completion Date

9/1/2027

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 Criteria

Age Range: 18 years to 85 years

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

Interventions

DEVICE

Hyperbaric Oxygen Therapy

OTHER

Sham Hyperbaric Air

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Conditions

Ulcerative Colitis

Locations

University of Alabama Medicine

Birmingham, Alabama 35233

United States

University of Los Angeles Health

Los Angeles, California 90024

United States

University of Miami Health

Miami, Florida 33136

United States

Orlando Health

Orlando, Florida 32806

United States

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois 60045

United States

University of Louisville

Louisville, Kentucky 40202

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Mayo Clinic

Rochester, Minnesota 55905

United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire 03756

United States

Cornell University Medical Center

New York, New York 10065

United States

State University of New York Upstate Medical University

Syracuse, New York 13210

United States

Allegheny Health

Pittsburgh, Pennsylvania 15090

United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania 15213

United States