Hyperbaric Oxygen Therapy for Ulcerative Colitis (HBOT-UC)

Launched by NORTHWESTERN UNIVERSITY · Aug 9, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the use of Hyperbaric Oxygen Therapy (HBOT) for patients with Ulcerative Colitis (UC), a condition that causes inflammation in the intestines. HBOT involves breathing pure oxygen while in a pressurized room, which helps deliver more oxygen to the body’s tissues. Previous smaller studies have shown that this treatment can help patients with moderate to severe UC flare-ups achieve better recovery and avoid the need for stronger medications or surgery. The goal of this larger trial is to confirm these benefits and understand how HBOT works at a biological level.

To be eligible for this trial, participants must be between the ages of 18 and 85, have either a known or newly diagnosed case of UC, and need to be hospitalized due to a moderate to severe flare-up. They should also be able to start HBOT within 48 hours of receiving intravenous steroids, which are medications used to reduce inflammation. Participants can expect to receive HBOT treatment while in the hospital and will be monitored closely throughout the study. It's important to note that individuals with certain complications or other specific health conditions cannot participate, and women who are pregnant or nursing are also excluded from the trial.

Gender

ALL

Eligibility criteria

• 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