Using hyperbaric oxygen therapy to treat ulcerative colitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Lauren Balmert Bonner, PhD — Northwestern University
• Study coordinator: Yasmin Pina, BS
• Email: yasmin.pina@northwestern.edu
• Phone: 312-503-6459

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.