RecruitingNot ApplicableNCT05987852

Hyperbaric Oxygen Therapy for Ulcerative Colitis (HBOT-UC)

Hyperbaric Oxygen Therapy for Ulcerative Colitis Patients Hospitalized for Moderate to Severe Flares: A Multi-Center, Randomized, Double-Blind, Sham-Controlled Trial

Sponsor

Northwestern University

Enrollment

126 participants

Start Date

Jan 9, 2024

Study Type

INTERVENTIONAL

Conditions

Ulcerative Colitis

Summary

Chronic intestinal hypoxia and accompanying mucosal inflammation is a hallmark of ulcerative colitis (UC). Hyperbaric oxygen therapy (HBOT) involves breathing 100% oxygen under increased atmospheric pressure to increase tissue oxygenation. Two small prospective randomized controlled trials have demonstrated that the delivery of HBOT to UC patients hospitalized for acute moderate to severe flares results in improved remission rates and avoidance of in-hospital progression to biologics, small molecules, or colectomy. In this larger trial the study aims to confirm the treatment benefits of HBOT for hospitalized UC patients and study the immune-microbe mechanisms underpinning treatment response.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether hyperbaric oxygen therapy (HBOT) — breathing pure oxygen in a pressurized chamber — can help people hospitalized with a severe flare of ulcerative colitis (a chronic inflammatory bowel disease), potentially reducing the need for surgery or steroids. **You may be eligible if...** - You have ulcerative colitis and are hospitalized for a moderate to severe flare - You are between 18 and 85 years old - You are able to receive the first HBOT session within 48 hours of starting intravenous treatment **You may NOT be eligible if...** - Your flare is mild and does not require hospitalization - You are outside the age range of 18-85 - You cannot begin HBOT within the required time window Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEHyperbaric Oxygen Therapy

Participants enrolled in the active intervention group receiving HBOT will undergo compression to 2.4 Atmospheres Absolute (ATA; 100% O2) for 90 minutes with two 5-10 minute "air breaks" (breathing room air at the 2.4 ATA) during the session. This is done once a day for 5 days.

OTHERSham Hyperbaric Air

This control arm will undergo compression to 1.34 ATA for monoplace chambers and 2.4 ATA for multiplace chambers for the full 90-minute session but 21% oxygen instead of 100% oxygen being administered. These participants will also have two 5-10 minute "air breaks" to mimic the treatment protocol. Multiplace sham sessions will have modified air breaks to avoid decompression sickness. This will happen once a day for 5 days.

Locations(13)

University of Alabama Medicine

Birmingham, Alabama, United States

University of Los Angeles Health

Los Angeles, California, United States

University of Miami Health

Miami, Florida, United States

Orlando Health

Orlando, Florida, United States

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, United States

University of Louisville

Louisville, Kentucky, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Cornell University Medical Center

New York, New York, United States

State University of New York Upstate Medical University

Syracuse, New York, United States

Allegheny Health

Pittsburgh, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

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NCT05987852

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