Hyperbaric Oxygen Therapy for Ulcerative Colitis

a study on Inflammatory Bowel Disease Ulcerative Colitis

Summary

Eligibility
for people ages 18-85 (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

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

Keywords

Ulcerative Colitis, hyperbaric oxygen therapy, HBOT, hyperbaric oxygen, Colitis, Ulcer

Eligibility

You can join if…

Open to people ages 18-85

  • Participants with known or newly diagnosed UC who require hospitalization for an acute moderate to severe flare
  • Age 18-85
  • Consented and able to receive first HBOT session within first 48 hours of initiation of intravenous steroids

You CAN'T join if...

  • Complication requiring urgent surgical intervention
  • Toxic megacolon
  • Inability to receive intravenous steroids
  • Historically failed 3 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
  • Active SARS CoV 2 infection

Locations

  • University of Los Angeles Health accepting new patients
    Los Angeles California 90024 United States
  • Mayo Clinic accepting new patients
    Rochester Minnesota 55905 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Northwestern University
Links
Sign up for this study
ID
NCT05987852
Study Type
Interventional
Participants
Expecting 126 study participants
Last Updated
Contact us about this trial