Hyperbaric Oxygen Therapy for Ulcerative Colitis (HBOT-UC)
- Conditions
- Ulcerative Colitis
- Interventions
- Other: Sham Hyperbaric AirDevice: Hyperbaric Oxygen Therapy
- Registration Number
- NCT05987852
- Lead Sponsor
- Northwestern University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 126
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham Hyperbaric Air 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. Hyperbaric Oxygen Therapy 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.
- Primary Outcome Measures
Name Time Method 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 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 Outcome Measures
Name Time Method Endoscopic Remission Day 90 Proportion of participants achieving Endoscopic remission (Mayo endoscopic sub-score of 0)
Mucosal Healing Day 90 Proportion of participants achieving Mucosal Healing (Endoscopic sub-score 0 or 1 + Geboes histology score ≤ 2)
Clinical Remission Day 5 Proportion of participants achieving clinical remission (Full Mayo ≤ 2, with no sub-score \> 1)
Colectomy Day 90; 12 month Proportion of participants requiring colectomy
Clinical Response Day 3 Sum of Mayo rectal bleeding and stool frequency sub-scores (Key secondary endpoint)
Change in inflammation, as measured by C-reactive protein Day 3 Change in inflammation, as measured by C-reactive protein (Key secondary endpoint)
Endoscopic response Day 5 Ulcerative Colitis Endoscopic Index of Severity (UCEIS) (Key secondary endpoint)
Steroid-free, colectomy-free, clinical remission Day 90 Proportion of participants steroid-free, colectomy-free, and with clinical remission (Full Mayo ≤ 2, with no sub-score \> 1)
Endoscopic Improvement Day 90 Proportion of participants achieving endoscopic improvement (Mayo endoscopic sub-score of 0 or 1)
Re-hospitalization for ulcerative colitis flare 12 months Proportion of participants with re-hospitalization during the follow-up period for ulcerative colitis flare
Numeric Urgency Rating Score Day 3 Score ranges from 0-10 ; higher scores are worse
Serious Infections or Serious Adverse Events Day 5 Proportion of participants experiencing any serious infections or serious adverse events during intervention period
Trial Locations
- Locations (13)
University of Alabama Medicine
🇺🇸Birmingham, Alabama, United States
University of Los Angeles Health
🇺🇸Los Angeles, California, United States
University of Miami Health
🇺🇸Miami, Florida, United States
Orlando Health
🇺🇸Orlando, Florida, United States
Northwestern Medicine Lake Forest Hospital
🇺🇸Lake Forest, Illinois, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Cornell University Medical Center
🇺🇸New York, New York, United States
State University of New York Upstate Medical University
🇺🇸Syracuse, New York, United States
Allegheny Health
🇺🇸Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States