Ulcerative Colitis study: Hyperbaric Oxygen Therapy
Official title Hyperbaric Oxygen Therapy for Ulcerative Colitis (HBOT-UC)
ClinicalTrials.gov ID: NCT05987852
What this study is testing
- What it's testing
- The study wants to see if breathing pure oxygen at high pressure helps hospitalized ulcerative colitis patients get better and avoid stronger drugs or surgery, and to learn how the treatment affects the immune system and gut bacteria.
- Who it's for
- Hospitalized adults with moderate to severe ulcerative colitis flares.
- What's involved
- Participants will breathe 100% oxygen in a pressurized chamber several times a week while receiving usual care, and will have blood, stool, and imaging tests to monitor changes.
- Time commitment
- The trial lasts about 6 weeks, with daily oxygen sessions and regular hospital visits for monitoring and testing.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join 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 likely can't join 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...
- Toxic megacolon
- Inability to receive intravenous steroids
- Historically failed or been exposed to 4 or more classes of advanced therapeutic options
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Los Angeles, California, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Lake Forest, Illinois, United States
- Louisville, Kentucky, United States
- Boston, Massachusetts, United States
- Rochester, Minnesota, United States
- Lebanon, New Hampshire, United States
- Syracuse, New York, United States
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Los Angeles, California, United States; Miami, Florida, United States; Orlando, Florida, United States; Lake Forest, Illinois, United States; Louisville, Kentucky, United States and 5 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.