Using hyperbaric oxygen therapy to treat ulcerative colitis
Hyperbaric Oxygen Therapy for Ulcerative Colitis Patients Hospitalized for Moderate to Severe Flares: A Multi-Center, Randomized, Double-Blind, Sham-Controlled Trial
This study is testing whether hyperbaric oxygen therapy can help hospitalized patients with ulcerative colitis feel better and reduce the need for stronger treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Northwestern University Academic / other |
| Drugs / interventions | radiation |
| Locations | 13 sites (Birmingham, Alabama and 12 other locations) |
| Trial ID | NCT05987852 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of hyperbaric oxygen therapy (HBOT) on patients with ulcerative colitis (UC) who are hospitalized for acute moderate to severe flares. The study aims to confirm previous findings that HBOT can improve remission rates and reduce the need for more aggressive treatments like biologics or colectomy. Participants will receive either HBOT or a sham treatment, and the trial will also explore the immune-microbe mechanisms that may explain the treatment's effectiveness. The goal is to provide a larger dataset to validate the benefits of HBOT in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-85 with known or newly diagnosed ulcerative colitis requiring hospitalization for an acute flare.
Not a fit: Patients who have previously received hyperbaric oxygen therapy or those with severe complications requiring urgent surgical intervention may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve remission rates for patients with ulcerative colitis during acute flares.
How similar studies have performed: Previous smaller trials have shown promising results for hyperbaric oxygen therapy in ulcerative colitis, suggesting potential for success in this larger study.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Birmingham, Alabama and 12 other locations
- 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)
Study contacts
- Principal investigator: Lauren Balmert Bonner, PhD — Northwestern University
- Study coordinator: Yasmin Pina, BS
- Email: yasmin.pina@northwestern.edu
- Phone: 312-503-6459
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.