Hyperbaric Oxygen Therapy for Ulcerative Colitis (HBOT-UC)
HBOT-UC
2 other identifiers
interventional
126
1 country
13
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2024
Longer than P75 for not_applicable
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2023
CompletedFirst Posted
Study publicly available on registry
August 14, 2023
CompletedStudy Start
First participant enrolled
January 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
January 8, 2026
January 1, 2026
3.6 years
August 1, 2023
January 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Proportion of participants achieving clinical response as measured by complete resolution of rectal bleeding (Mayo rectal bleeding sub-score of 0) and improvement in stool frequency (at least 1 point reduction in Mayo stool frequency sub-score), without the need for in-hospital biologics, small molecules, or colectomy, by study day 5.
Day 5
Secondary Outcomes (12)
Clinical Response
Day 3
Change in inflammation, as measured by C-reactive protein
Day 3
Endoscopic response
Day 5
Steroid-free, colectomy-free, clinical remission
Day 90
Endoscopic Improvement
Day 90
- +7 more secondary outcomes
Study Arms (2)
Hyperbaric Oxygen Therapy
EXPERIMENTALParticipants 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.
Sham Hyperbaric Air
SHAM COMPARATORThis 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
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
Related Publications (1)
Bonner LB, Sadler C, Lindholm P, Scholtens DM, Dulai PS; HBOT-UC Consortium. Hyperbaric oxygen therapy for ulcerative colitis patients hospitalized for moderate to severe flares (HBOT-UC): study protocol for a multi-center, randomized, double-blind, sham-controlled trial. Trials. 2025 Jun 22;26(1):220. doi: 10.1186/s13063-025-08932-5.
PMID: 40545548DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lauren Balmert Bonner, PhD
Northwestern University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 1, 2023
First Posted
August 14, 2023
Study Start
January 9, 2024
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
September 1, 2027
Last Updated
January 8, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
Dataset with National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Repository.