UCRecruiting
Hyperbaric Oxygen Therapy for Ulcerative Colitis (HBOT-UC)
Not applicable · Testing Hyperbaric Oxygen Therapy · 13 sites · Northwestern University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Hyperbaric Oxygen Therapy (a device) as a possible treatment. Condition(s) listed: Ulcerative Colitis.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 85
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 2 more requirement(s). There are also 11 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 126 participants are expected to take part.
- Start date: 2024-01-09.
- Main results expected around 2027-09-01 (estimate from the record).
- 13 study sites listed (12 marked recruiting) in United States.
Main thing being measured
- 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)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Ulcerative Colitis |
| Lead sponsor | Northwestern University |
| Collaborators | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Enrollment | 126 (estimated) |
| Start date | 2024-01-09 |
| Primary completion (est.) | 2027-09-01 |
| First posted | 2023-08-14 |
| Last updated | 2026-01-08 |
| Official title | Hyperbaric Oxygen Therapy for Ulcerative Colitis Patients Hospitalized for Moderate to Severe Flares: A Multi-Center, Randomized, Double-Blind, Sham-Controlled Trial |
| ClinicalTrials.gov ID | NCT05987852 |
Interventions
- Hyperbaric Oxygen Therapy (Device)
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. - Sham Hyperbaric Air (Other)
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 happ…
Full eligibility criteria (from the record)
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
Locations (13)
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alabama Medicine | Birmingham, Alabama | United States | Recruiting |
| University of Los Angeles Health | Los Angeles, California | United States | Recruiting |
| University of Miami Health | Miami, Florida | United States | Recruiting |
| Orlando Health | Orlando, Florida | United States | Recruiting |
| Northwestern Medicine Lake Forest Hospital | Lake Forest, Illinois | United States | Recruiting |
| University of Louisville | Louisville, Kentucky | United States | Recruiting |
| Massachusetts General Hospital | Boston, Massachusetts | United States | Recruiting |
| Mayo Clinic | Rochester, Minnesota | United States | Recruiting |
| Dartmouth Hitchcock Medical Center | Lebanon, New Hampshire | United States | Recruiting |
| Cornell University Medical Center | New York, New York | United States | Active, not recruiting |
| State University of New York Upstate Medical University | Syracuse, New York | United States | Recruiting |
| Allegheny Health | Pittsburgh, Pennsylvania | United States | Recruiting |
| University of Pittsburgh Medical Center | Pittsburgh, Pennsylvania | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.