Hyperbaric Oxygen Therapy for Ulcerative Colitis (HBOT-UC)

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
Able to fully participate in all aspects of the trial
Consented and able to receive first HBOT session within first 48 hours of initiation of intravenous steroids
Agreement to not participate in another trial for the duration of the active intervention period

Exclusion Criteria:

Received hyperbaric oxygen therapy either as part of standard of care or through a clinical trial prior to enrollment
Complication requiring urgent surgical intervention
Requirement for new start of a biologic or small molecule during the hospitalization prior to randomization and/or anticipated requirement for rescue medical or surgical therapy within 48 hours of randomization
Toxic megacolon
Inability to receive intravenous steroids
Historically failed or been exposed to 4 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