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Hyperbaric Oxygen Therapy for Ulcerative Colitis

Hyperbaric Oxygen Therapy for Ulcerative Colitis

Recruiting
18-85 years
All
Phase N/A

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Overview

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study details
    Ulcerative Colitis

NCT05987852

Northwestern University

30 April 2024

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