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NCT Number: NCT05987852

Hyperbaric Oxygen Therapy for Ulcerative Colitis (HBOT-UC)

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama Medicine, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hyperbaric oxygen therapy

Device

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

Other

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 outcomes

  1. 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

    Proportion of participants achieving clinical response as measured by complete resolution of rectal bleeding (Mayo rectal bleeding sub-score of 0) and improvement in stool frequency (at least 1 point reduction in Mayo stool frequency sub-score), without the need for in-hospital biologics, small molecules, or colectomy, by study day 5.

Secondary outcomes

  1. Clinical Response

    Time frame: Day 3

    Sum of Mayo rectal bleeding and stool frequency sub-scores (Key secondary endpoint)

  2. Change in inflammation, as measured by C-reactive protein

    Time frame: Day 3

    Change in inflammation, as measured by C-reactive protein (Key secondary endpoint)

  3. Endoscopic response

    Time frame: Day 5

    Ulcerative Colitis Endoscopic Index of Severity (UCEIS) (Key secondary endpoint)

  4. Steroid-free, colectomy-free, clinical remission

    Time frame: Day 90

    Proportion of participants steroid-free, colectomy-free, and with clinical remission (Full Mayo ≤ 2, with no sub-score > 1)

  5. Endoscopic Improvement

    Time frame: Day 90

    Proportion of participants achieving endoscopic improvement (Mayo endoscopic sub-score of 0 or 1)

  6. Endoscopic Remission

    Time frame: Day 90

    Proportion of participants achieving Endoscopic remission (Mayo endoscopic sub-score of 0)

  7. Mucosal Healing

    Time frame: Day 90

    Proportion of participants achieving Mucosal Healing (Endoscopic sub-score 0 or 1 + Geboes histology score ≤ 2)

  8. Clinical Remission

    Time frame: Day 5

    Proportion of participants achieving clinical remission (Full Mayo ≤ 2, with no sub-score > 1)

  9. Colectomy

    Time frame: Day 90; 12 month

    Proportion of participants requiring colectomy

  10. Re-hospitalization for ulcerative colitis flare

    Time frame: 12 months

    Proportion of participants with re-hospitalization during the follow-up period for ulcerative colitis flare

  11. Numeric Urgency Rating Score

    Time frame: Day 3

    Score ranges from 0-10 ; higher scores are worse

  12. Serious Infections or Serious Adverse Events

    Time frame: Day 5

    Proportion of participants experiencing any serious infections or serious adverse events during intervention period

Study contacts

Contact information is provided by the study sponsor or research team.

Mary Beth Tull, MS

CONTACT

[email protected]

312-503-4746

Yasmin Pina, BS

CONTACT

[email protected]

312-503-6459

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Acronym: HBOT-UC

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 14, 2023
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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