A multi-site clinical trial is currently enrolling patients to investigate the efficacy of hyperbaric oxygen therapy (HBOT) in treating ulcerative colitis. Led by principal investigator Dr. Oriana Damas at the University of Miami Miller School of Medicine, the study aims to determine whether HBOT can effectively reduce inflammation and improve clinical outcomes in patients with this debilitating inflammatory bowel disease.
The trial involves patients breathing 100% oxygen under increased pressure, a process designed to boost tissue oxygenation in the colon. Previous small clinical trials have suggested that HBOT can induce remission in hospitalized ulcerative colitis patients, and it has also shown promise in treating Crohn’s disease.
HBOT to Enhance Oxygen Delivery
Ulcerative colitis, characterized by inflammation of the large intestine, often results in reduced oxygen levels in the affected areas. HBOT's mechanism of action involves increasing oxygen delivery to these inflamed regions, potentially mitigating the inflammatory response. HBOT is already utilized in treating diabetic ulcers and poorly healing post-surgical wounds, where it enhances tissue oxygenation, reduces inflammatory proteins, stimulates cell growth, and promotes stem cell migration.
Dr. Damas notes that while various drug therapies exist for ulcerative colitis and inflammatory bowel diseases, predicting patient response remains a challenge. Some patients do not respond to any available treatments, while others experience only temporary relief. The research team believes that HBOT, similar to an anti-inflammatory diet, may serve as a valuable adjunctive treatment to medication, improving clinical results.
Trial Design and Patient Selection
The clinical trial focuses on patients hospitalized for ulcerative colitis and receiving intravenous steroids. Participants are randomized into two groups: one receiving HBOT and the other serving as a control group within the hyperbaric chamber but without active treatment. Researchers will evaluate endoscopy results and other relevant measures before and after the intervention to assess improvements in the HBOT group.
The investigators are optimistic about the interdisciplinary nature of the project, with close collaboration between the gastroenterology and hyperbaric medicine teams. Their ultimate goal is to reduce the necessity for surgery and alleviate inflammation in patients admitted for ulcerative colitis flare-ups, potentially improving the overall management of this chronic condition.