Ulcerative ColitisHBOT-UCNCT05987852
Hyperbaric Oxygen Therapy for Ulcerative Colitis (HBOT-UC)
A study testing Hyperbaric Oxygen Therapy in people with Ulcerative Colitis, run by Northwestern University at 13 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Hyperbaric Oxygen Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 13 sitesUnited States
- Study dates
- 9 Jan 2024to 1 Sep 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
United States13 sites, 12 recruiting
- Recruiting
University of Alabama Medicine
Birmingham, Alabama, 35233
Kirk Russ, MD, kruss@uabmc.edu
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Ashwin Ananthakrishnan, MD, aananthakrishnan@mgh.harvard.edu
- Recruiting
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045
Parambir S Dulai, MD, parambir.dulai@northwestern.edu
- Recruiting
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Corey Siegel, MD, corey.a.siegel@hitchcock.org
Michael Winter, MD, michael.w.winter@hitchcock.org
- Recruiting
University of Los Angeles Health
Los Angeles, California, 90024
Jenny Sauk, MD, jsauk@mednet.ucla.edu
- Recruiting
University of Louisville
Louisville, Kentucky, 40202
Gerald Dryden, MD, tad.dryden@louisville.edu
- Recruiting
University of Miami Health
Miami, Florida, 33136
Oriana Damas, MD, omazorra@med.miami.edu
- Active, not recruiting
Cornell University Medical Center
New York, New York, 10065
- Recruiting
Orlando Health
Orlando, Florida, 32806
Udayakumar Navaneethan, MD, udayakumar.navaneethan@orlandohealth.com
- Recruiting
Allegheny Health
Pittsburgh, Pennsylvania, 15090
Aakash Desai, MD, Aakash.Desai@ahn.org
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Jeffrey Dueker, MD, duekerjm@upmc.edu
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Laura Raffals, MD, raffals.laura@mayo.edu
- Recruiting
State University of New York Upstate Medical University
Syracuse, New York, 13210
Idan Goren, MD, GorenI@upstate.edu
About this study
Official title: Hyperbaric Oxygen Therapy for Ulcerative Colitis Patients Hospitalized for Moderate to Severe Flares: A Multi-Center, Randomized, Double-Blind, Sham-Controlled Trial
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
- Being tested
- Hyperbaric Oxygen Therapy, Sham Hyperbaric Air
- Keywords
- hyperbaric oxygen therapy, HBOT, ulcerative colitis, hyperbaric oxygen
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygen TherapyDevice
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 AirOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric Oxygen Therapy | Experimental | 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. Receives: Device: Hyperbaric Oxygen Therapy |
| Sham Hyperbaric Air | Sham comparator | 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. Receives: Other: Sham Hyperbaric Air |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: Day 5
Secondary outcomes (12)
Clinical Response
Sum of Mayo rectal bleeding and stool frequency sub-scores (Key secondary endpoint)
Measured: Day 3
Change in inflammation, as measured by C-reactive protein
Change in inflammation, as measured by C-reactive protein (Key secondary endpoint)
Measured: Day 3
Endoscopic response
Ulcerative Colitis Endoscopic Index of Severity (UCEIS) (Key secondary endpoint)
Measured: Day 5
Steroid-free, colectomy-free, clinical remission
Proportion of participants steroid-free, colectomy-free, and with clinical remission (Full Mayo ≤ 2, with no sub-score > 1)
Measured: Day 90
Endoscopic Improvement
Proportion of participants achieving endoscopic improvement (Mayo endoscopic sub-score of 0 or 1)
Measured: Day 90
Endoscopic Remission
Proportion of participants achieving Endoscopic remission (Mayo endoscopic sub-score of 0)
Measured: Day 90
Mucosal Healing
Proportion of participants achieving Mucosal Healing (Endoscopic sub-score 0 or 1 + Geboes histology score ≤ 2)
Measured: Day 90
Clinical Remission
Proportion of participants achieving clinical remission (Full Mayo ≤ 2, with no sub-score > 1)
Measured: Day 5
Colectomy
Proportion of participants requiring colectomy
Measured: Day 90; 12 month
Re-hospitalization for ulcerative colitis flare
Proportion of participants with re-hospitalization during the follow-up period for ulcerative colitis flare
Measured: 12 months
Numeric Urgency Rating Score
Score ranges from 0-10 ; higher scores are worse
Measured: Day 3
Serious Infections or Serious Adverse Events
Proportion of participants experiencing any serious infections or serious adverse events during intervention period
Measured: Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start9 Jan 2024
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 5-day intervention period; 12 months observational period through standard of care visits and follow-up
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Parambir Dulai, Northwestern University
- Investigators
- Lauren Balmert Bonner, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05987852
- Sponsor's protocol ID
- HBOT-UC
- Other IDs
- 1U01DK134321
- Acronym
- HBOT-UC
- Status last verified
- Oct 2026
- First submitted
- 1 Aug 2023
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Dataset with National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Repository.
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.
PubMed 40545548Honap 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.
PubMed 38834296