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RECRUITING
NCT05987852
NA

Hyperbaric Oxygen Therapy for Ulcerative Colitis (HBOT-UC)

Sponsor: Northwestern University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

126

Start Date

2024-01-09

Completion Date

2027-09-01

Last Updated

2026-01-08

Healthy Volunteers

No

Interventions

DEVICE

Hyperbaric 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.

OTHER

Sham 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