Hyperbaric Oxygen Therapy for Ulcerative Colitis (HBOT-UC)

Northwestern University

Status: Enrolling

Conditions: Ulcerative Colitis

Treatments: Other: Sham Hyperbaric Air; Device: Hyperbaric Oxygen Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05987852

HBOT-UC

1U01DK134321 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 126 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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126 participants in 2 patient groups

Hyperbaric Oxygen Therapy

Experimental group

Description:

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.

Treatment:

Device: Hyperbaric Oxygen Therapy

Sham Hyperbaric Air

Sham Comparator group

Description:

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.

Treatment:

Other: Sham Hyperbaric Air