January 2024

GASTROENTEROLOGY

HYPERBARIC OXYGEN THERAPY FOR ULCERATIVE COLITIS

Featuring: Parambir S. Dulai, MD
People with moderate to severe ulcerative colitis (UC) may soon benefit from a treatment that is well known for healing chronic wounds: hyperbaric oxygen therapy. In a recent study of patients who were hospitalized due to severe UC symptoms, hyperbaric oxygen therapy resulted in clinical improvements that helped patients avoid surgery and immunosuppressant medication. The study, led by Northwestern Medicine Gastroenterologist Parambir S. Dulai, MD, also defined the ways that hyperbaric oxygen therapy functions to improve inflammation in UC, ultimately improving quality of life for patients.
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“Patients with ulcerative colitis have a breakdown of the lining of the colon, and immune cells come into the colon to try to help it heal,” says Dr. Dulai. “Immune cells consume all the oxygen as they try to fight off bad bacteria, but this eventually leads to a lack of oxygen in the tissue and makes it difficult for the healing process to occur. Hyperbaric oxygen therapy is a way to push oxygen into the colon through its tiny blood vessels. This kills the inflammation-causing bad bacteria that thrive in these low-oxygen environments. It resets the immune system and allows the colon to heal.”

For the study, which was detailed in an article published in Cellular and Molecular Gastroenterology and Hepatology, Dr. Dulai and his colleagues placed patients in the hyperbaric chambers for two hours a day for five consecutive days. While in the chamber, patients received pressurized 100% oxygen, and the results surpassed even the researchers’ expectations.

“Within five days, their bleeding was gone,” says Dr. Dulai. The patients were seriously ill and were a few days away from having their colons removed. “When you get to that point with ulcerative colitis, you’re no longer eligible for pharmaceutical trials, and few treatments have been studied for these patients.”

Dr. Dulai has begun an 18-site, three-year phase 3 clinical trial funded by the National Institutes of Health to further study the use of hyperbaric oxygen therapy to treat patients who are hospitalized for UC flares.
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“There have been no clinical trials in this population in the U.S. for hospitalized ulcerative colitis patients, and very few internationally,” says Dr. Dulai, who is working with Northwestern University Data Analysis and Coordinating Center Lead Lauren Balmert Bonner, PhD, as well as colleagues at Northwestern Medicine Lake Forest Hospital, which is home to the health system’s in-hospital hyperbaric chambers.
Northwestern Medicine offers hyperbaric oxygen therapy at many off-site locations, and more than 1,300 hospitals across the nation have chambers on-site.

The phase 3 clinical trial is studying another element of hyperbaric oxygen therapy: its long-term effectiveness in the treatment of UC. It is examining how patients are doing 12 months after their initial treatments.

“It will provide a framework so we can understand the durability of this approach in the outpatient setting,” Dr. Dulai explains. “We will also learn more about whether we need to provide outpatient treatments to maintain the response to hyperbaric therapy.”
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“We have great medications for ulcerative colitis, but at the same time, 70% of people will lose response to them within a few years,” says Dr. Dulai. “At least half of the people who have ulcerative colitis will be hospitalized at some point in their disease. To realize a simple treatment like hyperbaric oxygen therapy could have life-changing benefits for these patients is very exciting. Many of the patients we treated are still sending us thanks for the care they received.”

Stakes are high for UC patients who no longer respond to traditional treatment methods: Emergency colectomy (colon removal) mortality rates are “significant,” especially in centers not experienced with this surgery. Colectomies performed at centers with low experience and volume have mortality rates up to 2.5 times higher than centers with more experience and volume. And when these surgeries are delayed more than 14 days after hospital admission, mortality rates can rise as high as 3 to 5 times that of colectomies done earlier in the hospital admission. This underlines the importance of having an ideal trial design that is seamless for patients and integrated into routine care workflows.

Research up to this point has been limited by several complicating factors, including:
  • Difficulty amassing enough patients with a severe enough case of the condition
  • Lack of clarity from regulatory bodies on what the ideal end-points are for trials in this population
  • The danger of establishing an experiment control group by giving a placebo to patients who need immediate treatment

Dr. Dulai and team implemented innovative measures to overcome those barriers. “In order to get this study operational, we had to do many creative things,” he says. The investigators are:
  • Using a large consortium of sites across the country along with novel approaches to data collection and follow-up spearheaded by the Northwestern Data Coordinating Center
  • Applying unique measures of disease activity to help better capture the complexity and severity of this acutely ill population
  • Including patients in every step

“We needed to ensure the patient voice was heard when designing this study and that the trial was created in a way that was functional for patients, while ensuring scientific rigor,” Dr. Dulai explains. “To accomplish this, we created a committee composed of patients and providers to guide us on the appropriate design of the trial and what we should be measuring that was important to them. By including patients in the process, we hope our work will be even more relevant and help guide the future for how trials in these high-risk patients are conducted.”

“We are very hopeful for continued good results in phase 3 of our study,” Dr. Dulai adds. “The ramifications of our findings with hyperbaric oxygen treatment could greatly increase survival and quality of life for UC patients.”

The study is actively recruiting. People interested in enrolling can view the trial information on clinicaltrials.gov to see which locations are participating and email Dr. Dulai directly.
Parambir S. Dulai, MD,, Associate Professor of Gastroenterology and Hepatology in the Department of Medicine.

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