Recruiting

HBOT-UC

Sponsor:

Northwestern University

Code:

NCT05987852

Conditions

Ulcerative Colitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Hyperbaric Oxygen Therapy

Sham Hyperbaric Air

Study Details

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.

Conditions

Ulcerative Colitis

Study ID

NCT05987852

Start date

Jan 9, 2024

Status verified date

Jan, 2026

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

126 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Hyperbaric Oxygen Therapy

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.

sham comparator: Sham Hyperbaric Air

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.

Interventions

Hyperbaric Oxygen Therapy

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.

Sham Hyperbaric Air

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.

Primary outcome measure

  • Clinical response defined as complete resolution of rectal bleeding and improvement in stool frequency, without need for in-hospital biologics, small molecules, or colectomy by study day 5 [ Time Frame: Day 5 ]

Central Contacts and Locations

Central contacts

Yasmin Pina, BS

312-503-6459yasmin.pina@northwestern.edu

Mary Beth Tull, MS

312-503-4746mary.tull@northwestern.edu

Locations

University of Alabama Medicine

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Kirk Russ, MD

kruss@uabmc.edu

University of Los Angeles Health

Recruiting

Los Angeles, California, United States, 90024

Contacts

Jenny Sauk, MD

jsauk@mednet.ucla.edu

University of Miami Health

Recruiting

Miami, Florida, United States, 33136

Contacts

Oriana Damas, MD

omazorra@med.miami.edu

Orlando Health

Recruiting

Orlando, Florida, United States, 32806

Contacts

Udayakumar Navaneethan, MD

udayakumar.navaneethan@orlandohealth.com

Northwestern Medicine Lake Forest Hospital

Recruiting

Lake Forest, Illinois, United States, 60045

Contacts

Parambir S Dulai, MD

parambir.dulai@northwestern.edu

University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Gerald Dryden, MD

tad.dryden@louisville.edu

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Ashwin Ananthakrishnan, MD

aananthakrishnan@mgh.harvard.edu

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Laura Raffals, MD

raffals.laura@mayo.edu

Dartmouth Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Corey Siegel, MD

corey.a.siegel@hitchcock.org

Michael Winter, MD

michael.w.winter@hitchcock.org

State University of New York Upstate Medical University

Recruiting

Syracuse, New York, United States, 13210

Contacts

Idan Goren, MD

GorenI@upstate.edu

Allegheny Health

Recruiting

Pittsburgh, Pennsylvania, United States, 15090

Contacts

Aakash Desai, MD

Aakash.Desai@ahn.org

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Jeffrey Dueker, MD

duekerjm@upmc.edu

More Information

Sponsor

Northwestern University

Last update posted

Jan 8, 2026

Last verified

Jan, 2026

Keywords

  • hyperbaric oxygen therapy
  • HBOT
  • ulcerative colitis
  • hyperbaric oxygen

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-01-08.