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Recruiting NCT05987852

Hyperbaric Oxygen Therapy for Ulcerative Colitis (HBOT-UC)

No phase Interventional Ulcerative Colitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hyperbaric Oxygen Therapy, Sham Hyperbaric Air.
Who it may be relevant to
Registry conditions: Ulcerative Colitis. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Hyperbaric Oxygen Therapy for Ulcerative Colitis Patients Hospitalized for Moderate to Severe Flares: A Multi-Center, Randomized, Double-Blind, Sham-Controlled Trial

Overview

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.

Interventions

  • Device 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.
  • Other 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 measures

  • 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]
Secondary outcome measures (12)
  • Clinical Response [Time frame: Day 3]
  • Change in inflammation, as measured by C-reactive protein [Time frame: Day 3]
  • Endoscopic response [Time frame: Day 5]
  • Steroid-free, colectomy-free, clinical remission [Time frame: Day 90]
  • Endoscopic Improvement [Time frame: Day 90]
  • Endoscopic Remission [Time frame: Day 90]
  • Mucosal Healing [Time frame: Day 90]
  • Clinical Remission [Time frame: Day 5]
  • Colectomy [Time frame: Day 90; 12 month]
  • Re-hospitalization for ulcerative colitis flare [Time frame: 12 months]
  • Numeric Urgency Rating Score [Time frame: Day 3]
  • Serious Infections or Serious Adverse Events [Time frame: Day 5]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 13 centers
  • University of Alabama Medicine — Birmingham
  • University of Los Angeles Health — Los Angeles
  • University of Miami Health — Miami
  • Orlando Health — Orlando
  • Northwestern Medicine Lake Forest Hospital — Lake Forest
  • University of Louisville — Louisville
  • Massachusetts General Hospital — Boston
  • Mayo Clinic — Rochester
  • … and 5 more centers

Publications

  • Bonner LB, Sadler C, Lindholm P, Scholtens DM, Dulai PS; HBOT-UC Consortium. Hyperbaric oxygen therapy for ulcerative colitis patients hospitalized for moderate to severe flares (HBOT-UC): study protocol for a multi-center, randomized, double-blind, sham-controlled trial. Trials. 2025 Jun 22;26(1):220. doi: 10.1186/s13063-025-08932-5. PMID 40545548
  • Honap S, Jairath V, Sands BE, Dulai PS, Danese S, Peyrin-Biroulet L. Acute severe ulcerative colitis trials: the past, the present and the future. Gut. 2024 Sep 9;73(10):1763-1773. doi: 10.1136/gutjnl-2024-332489. PMID 38834296

Identifiers

NCT: NCT05987852 · HBOT-UC · 1U01DK134321

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗