Hyperbaric Oxygen Therapy for Ulcerative Colitis (HBOT-UC)

Last updated: January 6, 2026
Sponsor: Northwestern University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ulcerative Colitis

Bowel Dysfunction

Inflammatory Bowel Disease

Treatment

Hyperbaric Oxygen Therapy

Sham Hyperbaric Air

Clinical Study ID

NCT05987852
HBOT-UC
1U01DK134321
  • Ages 18-85
  • All Genders

Study 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

Inclusion

Inclusion Criteria:

  • Participants with known or newly diagnosed UC who require hospitalization for anacute 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 initiationof intravenous steroids

  • Agreement to not participate in another trial for the duration of the activeintervention period

Exclusion

Exclusion Criteria:

  • Received hyperbaric oxygen therapy either as part of standard of care or through aclinical trial prior to enrollment

  • Complication requiring urgent surgical intervention

  • Requirement for new start of a biologic or small molecule during the hospitalizationprior to randomization and/or anticipated requirement for rescue medical or surgicaltherapy within 48 hours of randomization

  • Toxic megacolon

  • Inability to receive intravenous steroids

  • Historically failed or been exposed to 4 or more classes of advanced therapeuticoptions

  • Known or suspected diagnosis of Crohn's colitis, indeterminate colitis, ischemiccolitis, 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 orhepatic impairment that increases the risk for HBOT toxicity

  • Women who are pregnant or nursing

  • Unwillingness to complete course of HBOT

Study Design

Total Participants: 126
Treatment Group(s): 2
Primary Treatment: Hyperbaric Oxygen Therapy
Phase:
Study Start date:
January 09, 2024
Estimated Completion Date:
September 01, 2027

Connect with a study center

  • University of Alabama Medicine

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • University of Alabama Medicine

    Birmingham 4049979, Alabama 4829764 35233
    United States

    Active - Recruiting

  • University of Los Angeles Health

    Los Angeles, California 90024
    United States

    Site Not Available

  • University of Los Angeles Health

    Los Angeles 5368361, California 5332921 90024
    United States

    Active - Recruiting

  • University of Miami Health

    Miami, Florida 33136
    United States

    Site Not Available

  • Orlando Health

    Orlando, Florida 32806
    United States

    Site Not Available

  • University of Miami Health

    Miami 4164138, Florida 4155751 33136
    United States

    Active - Recruiting

  • Orlando Health

    Orlando 4167147, Florida 4155751 32806
    United States

    Active - Recruiting

  • Lake Forest Hospital

    Lake Forest, Illinois 60045
    United States

    Active - Recruiting

  • Northwestern Medicine Lake Forest Hospital

    Lake Forest, Illinois 60045
    United States

    Site Not Available

  • Northwestern Medicine Lake Forest Hospital

    Lake Forest 4899012, Illinois 4896861 60045
    United States

    Active - Recruiting

  • University of Louisville

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • University of Louisville

    Louisville 4299276, Kentucky 6254925 40202
    United States

    Active - Recruiting

  • University of Maryland Medical Center

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Tufts Medical Center

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Mayo Clinic

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Active - Recruiting

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • Dartmouth Hitchcock Medical Center

    Lebanon 5088597, New Hampshire 5090174 03756
    United States

    Active - Recruiting

  • Cornell University Medical Center

    New York, New York 10065
    United States

    Active - Recruiting

  • New York University Langone Health

    New York, New York 10016
    United States

    Site Not Available

  • State University of New York Upstate Medical University

    Syracuse, New York 13210
    United States

    Site Not Available

  • Cornell University Medical Center

    New York 5128581, New York 5128638 10065
    United States

    Site Not Available

  • State University of New York Upstate Medical University

    Syracuse 5140405, New York 5128638 13210
    United States

    Active - Recruiting

  • Oregon Health & Science University Health

    Portland, Oregon 97239
    United States

    Site Not Available

  • Allegheny Health

    Pittsburgh, Pennsylvania 15090
    United States

    Active - Recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Allegheny Health

    Pittsburgh 5206379, Pennsylvania 6254927 15090
    United States

    Active - Recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh 5206379, Pennsylvania 6254927 15213
    United States

    Active - Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • University of Virginia Health

    Charlottesville, Virginia 22903
    United States

    Site Not Available

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