Phase
Condition
Ulcerative Colitis
Bowel Dysfunction
Inflammatory Bowel Disease
Treatment
Hyperbaric Oxygen Therapy
Sham Hyperbaric Air
Clinical Study ID
Ages 18-85 All Genders
Study Summary
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
Connect with a study center
University of Alabama Medicine
Birmingham, Alabama 35233
United StatesSite Not Available
University of Alabama Medicine
Birmingham 4049979, Alabama 4829764 35233
United StatesActive - Recruiting
University of Los Angeles Health
Los Angeles, California 90024
United StatesSite Not Available
University of Los Angeles Health
Los Angeles 5368361, California 5332921 90024
United StatesActive - Recruiting
University of Miami Health
Miami, Florida 33136
United StatesSite Not Available
Orlando Health
Orlando, Florida 32806
United StatesSite Not Available
University of Miami Health
Miami 4164138, Florida 4155751 33136
United StatesActive - Recruiting
Orlando Health
Orlando 4167147, Florida 4155751 32806
United StatesActive - Recruiting
Lake Forest Hospital
Lake Forest, Illinois 60045
United StatesActive - Recruiting
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois 60045
United StatesSite Not Available
Northwestern Medicine Lake Forest Hospital
Lake Forest 4899012, Illinois 4896861 60045
United StatesActive - Recruiting
University of Louisville
Louisville, Kentucky 40202
United StatesSite Not Available
University of Louisville
Louisville 4299276, Kentucky 6254925 40202
United StatesActive - Recruiting
University of Maryland Medical Center
Baltimore, Maryland 21201
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
Tufts Medical Center
Boston, Massachusetts 02111
United StatesSite Not Available
Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
United StatesActive - Recruiting
Mayo Clinic
Rochester, Minnesota 55905
United StatesSite Not Available
Mayo Clinic
Rochester 5043473, Minnesota 5037779 55905
United StatesActive - Recruiting
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire 03756
United StatesSite Not Available
Dartmouth Hitchcock Medical Center
Lebanon 5088597, New Hampshire 5090174 03756
United StatesActive - Recruiting
Cornell University Medical Center
New York, New York 10065
United StatesActive - Recruiting
New York University Langone Health
New York, New York 10016
United StatesSite Not Available
State University of New York Upstate Medical University
Syracuse, New York 13210
United StatesSite Not Available
Cornell University Medical Center
New York 5128581, New York 5128638 10065
United StatesSite Not Available
State University of New York Upstate Medical University
Syracuse 5140405, New York 5128638 13210
United StatesActive - Recruiting
Oregon Health & Science University Health
Portland, Oregon 97239
United StatesSite Not Available
Allegheny Health
Pittsburgh, Pennsylvania 15090
United StatesActive - Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
Allegheny Health
Pittsburgh 5206379, Pennsylvania 6254927 15090
United StatesActive - Recruiting
University of Pittsburgh Medical Center
Pittsburgh 5206379, Pennsylvania 6254927 15213
United StatesActive - Recruiting
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesSite Not Available
University of Virginia Health
Charlottesville, Virginia 22903
United StatesSite Not Available

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