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Hyperbaric Oxygen Therapy for Ulcerative Colitis

About

Brief 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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
N/A

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
85 Years

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

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Study Stats
Protocol No.
23-5151
Category
GI Disorders
Contact
Xiaoxiao Yin
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05987852
For detailed technical eligibility, visit ClinicalTrials.gov.