TrialPath
← Back to searchRecruiting

Hyperbaric Oxygen Therapy for Ulcerative Colitis (HBOT-UC)

NCT05987852 · Northwestern University
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
Hyperbaric Oxygen Therapy for Ulcerative Colitis Patients Hospitalized for Moderate to Severe Flares: A Multi-Center, Randomized, Double-Blind, Sham-Controlled Trial
About this study
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 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
Study design
Enrollment target: 126 participants
Allocation: randomized
Masking: triple
Age groups: adult, older_adult
Timeline
Starts: 2024-01-09
Estimated completion: 2027-09-01
Last updated: 2026-01-08
Interventions
Device: Hyperbaric Oxygen TherapyOther: Sham Hyperbaric Air
Primary outcomes
  • Clinical response defined as complete resolution of rectal bleeding and improvement in stool frequency, without need for in-hospital biologics, small molecules, or colectomy by study day 5 (Day 5)
Sponsor
Northwestern University · other
With: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contacts & investigators
ContactYasmin Pina, BS · contact · yasmin.pina@northwestern.edu · 312-503-6459
ContactMary Beth Tull, MS · contact · mary.tull@northwestern.edu · 312-503-4746
InvestigatorLauren Balmert Bonner, PhD · principal_investigator, Northwestern University
All locations (13)
University of Alabama MedicineRecruiting
Birmingham, Alabama, United States
University of Los Angeles HealthRecruiting
Los Angeles, California, United States
University of Miami HealthRecruiting
Miami, Florida, United States
Orlando HealthRecruiting
Orlando, Florida, United States
Northwestern Medicine Lake Forest HospitalRecruiting
Lake Forest, Illinois, United States
University of LouisvilleRecruiting
Louisville, Kentucky, United States
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
Mayo ClinicRecruiting
Rochester, Minnesota, United States
Dartmouth Hitchcock Medical CenterRecruiting
Lebanon, New Hampshire, United States
Cornell University Medical CenterActive Not Recruiting
New York, New York, United States
State University of New York Upstate Medical UniversityRecruiting
Syracuse, New York, United States
Allegheny HealthRecruiting
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical CenterRecruiting
Pittsburgh, Pennsylvania, United States
Hyperbaric Oxygen Therapy for Ulcerative Colitis (HBOT-UC) · TrialPath