Ulcerative Colitis
Hyperbaric oxygen therapy for hospitalized ulcerative colitis flares
This study is testing hyperbaric oxygen therapy against a sham procedure in adults hospitalized with moderate-to-severe ulcerative colitis flares, with clinical response assessed by study day 5.
Registry title: Hyperbaric Oxygen Therapy for Ulcerative Colitis (HBOT-UC)
12 recruiting U.S. sites ↓Study at a glance
- Age
- 18 Years–85 Years
- Treatment
- Hyperbaric Oxygen Therapy or Sham Hyperbaric Air
- Design
- Randomized · Triple
- Central study contact
- Yasmin Pina, BS312-503-6459yasmin.pina@northwestern.edu
- Sponsor
- Northwestern University
Research question
Does hyperbaric oxygen therapy improve clinical response by study day 5 compared with a sham procedure in patients hospitalized for moderate-to-severe ulcerative colitis flares?
Participant snapshot
Who the study is looking for
- The study is looking for adults ages 18 through 85.
- The study is looking for people with known or newly diagnosed ulcerative colitis who require hospitalization for an acute moderate-to-severe flare.
- Participants must be able to receive their first hyperbaric oxygen therapy session within 48 hours after intravenous steroids begin.
- The registry lists recruiting hospital sites in several U.S. states, while one listed New York site is active but not recruiting.
Participation overview
What participation may involve
Participants receive either active hyperbaric oxygen therapy or a sham chamber procedure once daily for five days, followed by 12 months of observation through standard-care visits and follow-up. What participation may involve: - Complete one 90-minute assigned chamber session each day for five days, including two 5-to-10-minute air breaks. - Have ulcerative colitis symptoms assessed using rectal-bleeding and stool-frequency components of the Mayo score. - Undergo assessments of inflammation, endoscopic disease activity, histology, bowel urgency, infections, adverse events, colectomy, and rehospitalization at reported study timepoints. - Continue observational follow-up for 12 months through standard-care visits and follow-up. The assigned intervention lasts five days, followed by a 12-month observational period. The registry reports one chamber session per day for five days and later follow-up through standard-care visits, but it does not provide a complete visit schedule.
Study interventions
What participants may receive or do
- Hyperbaric Oxygen Therapy: Participants assigned to this group breathe 100% oxygen while compressed to 2.4 atmospheres absolute for 90 minutes. Each session includes two 5-to-10-minute room-air breaks and occurs once daily for five days.
- Sham Hyperbaric Air: Participants assigned to the control group undergo a 90-minute chamber session using 21% oxygen, with chamber pressure and air breaks designed to mimic the active treatment. Sessions occur once daily for five days.
Study design
How the comparison works
This is a randomized, parallel-group treatment study comparing five days of hyperbaric oxygen therapy with five days of a sham chamber procedure, followed by 12 months of observation through standard-care visits and follow-up. Participants are assigned randomly to one of two parallel groups. The registry describes triple masking: participants, investigators, and outcome assessors are masked to treatment assignment. The control group undergoes chamber compression and receives 21% oxygen during sessions designed to mimic the active-treatment protocol. The study uses a sham hyperbaric-air procedure rather than an inactive pill; the registry does not report the probability of assignment to either group.
Reported activities
Procedures and tests
- Ninety-minute hyperbaric chamber sessions with assigned oxygen conditions and two 5-to-10-minute air breaks.
- Rectal bleeding and stool frequency assessments using Mayo subscores.
- C-reactive protein assessment to measure change in inflammation.
- Endoscopic disease-activity assessments using the Ulcerative Colitis Endoscopic Index of Severity and Mayo endoscopic subscore.
- Histology assessment using the Geboes score as part of the mucosal-healing outcome.
- Bowel-urgency assessment using a numeric rating from 0 to 10.
- Monitoring for serious infections and serious adverse events during the five-day intervention period.
- Follow-up assessment of colectomy and rehospitalization for an ulcerative colitis flare.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must have known or newly diagnosed ulcerative colitis and require hospitalization for an acute moderate-to-severe flare.
- Participants must be 18 through 85 years old.
- Participants must be able to take part fully in every aspect of the trial.
- Consent and the first hyperbaric oxygen therapy session must occur within 48 hours after intravenous steroids begin.
- Participants must agree not to join another trial during the five-day active intervention period.
Possible reasons someone may not be able to join
- People who received hyperbaric oxygen therapy before enrollment, either as standard care or in a clinical trial, are excluded.
- A complication requiring urgent surgery excludes participation.
- People are excluded if they started a new biologic or small-molecule treatment during the hospitalization before randomization, or are expected to need rescue medical or surgical treatment within 48 hours after randomization.
- People with toxic megacolon are excluded.
- People unable to receive intravenous steroids are excluded.
- People who historically failed or were exposed to four or more classes of advanced therapies are excluded.
- People with known or suspected Crohn's colitis, indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease-associated colitis, microscopic colitis, or infectious colitis are excluded.
- Receiving an investigational drug within the previous 30 days excludes participation.
- Clinically significant cardiac, kidney, neurological, endocrine, respiratory, or liver impairment that increases hyperbaric oxygen therapy toxicity risk is exclusionary.
- Women who are pregnant or nursing are excluded.
- People unwilling to complete the full hyperbaric oxygen therapy course are excluded.
Important unknowns
What the record does not make clear
- The record specifies five daily chamber sessions and 12 months of observation through standard-care visits, but it does not provide the complete follow-up schedule or distinguish required research visits from routine care.
- The study has active and sham groups, but the record does not state the chance of assignment to either group.
- Eligibility requires intravenous steroids and restricts certain new therapies before randomization, but the record does not fully describe which ulcerative colitis treatments continue during the intervention and follow-up.
- The record excludes investigational-drug use within 30 days and certain treatment starts before randomization, but it does not give a complete medication washout plan.
- The study excludes people expected to need rescue treatment within 48 hours after randomization and tracks escalation to biologics, small molecules, or colectomy, but the record does not explain the rescue-treatment protocol after enrollment.
- The outcomes include endoscopic and histology measures at days 5 and 90, but the record does not clearly state which endoscopic procedures or tissue collections participants must undergo.
- The record does not state which study-related or standard-care costs are covered or billed to insurance.
- The record does not state whether participants receive compensation.
- The record does not state whether transportation, lodging, parking, or other travel support is available.
- The five chamber sessions require in-person treatment, while the record does not say whether any later follow-up can occur remotely or with a local clinician.
- The record lists multiple recruiting sites and one active-but-not-recruiting site, but current availability for a particular hospitalized patient must be confirmed directly.
Before contacting the site
Questions for the study team
- What is the chance of assignment to active hyperbaric oxygen therapy rather than the sham procedure?
- How do you arrange consent, screening, and the first chamber session within 48 hours after intravenous steroids begin?
- Which ulcerative colitis medicines and hospital treatments continue during the five-day intervention and follow-up?
- What rescue treatment is available if symptoms worsen, and what would trigger biologic therapy, a small molecule, or surgery?
- Which endoscopies, biopsies, blood tests, and symptom assessments are required, and at what timepoints?
- What is the complete schedule after the five daily chamber sessions, and can any follow-up occur remotely or locally?
- Which study and hospital costs are covered, is compensation offered, and is travel support available?
- Which sites are currently able to enroll a hospitalized patient and begin treatment within the required window?
Before changing care
Questions for your gastroenterologist
- How would my current ulcerative colitis medicines and intravenous steroid plan need to be coordinated with this study?
- Given the severity and course of my flare, how urgent is treatment escalation, and could trial screening delay standard care?
- What approved treatment alternatives are available for this flare, including biologics, small molecules, or surgery?
- Do my other health conditions or prior advanced therapies raise concerns about hyperbaric oxygen therapy or the study criteria?
- How would you coordinate follow-up, endoscopic assessment, and any urgent treatment decisions with the research team?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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.
Study design and administration
- Organization
- Northwestern University
- Organization class
- Other
- Organization study ID
- HBOT-UC
- Lead sponsor
- Northwestern University
- Sponsor class
- Other
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- Triple
- Who is masked
- Participant, Investigator, Outcomes Assessor
- Standard age groups
- Adult, Older Adult
Study 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.
Interventions: Device: Hyperbaric Oxygen Therapy
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: Other: Sham Hyperbaric Air
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.
Eligibility
18 Years–85 Years
All
Not accepted
Inclusion criteria (5)
- Participants with known or newly diagnosed UC who require hospitalization for an acute moderate to severe flareRegistry-derived · unreviewed
- Age 18-85Registry-derived · unreviewed
- Able to fully participate in all aspects of the trialRegistry-derived · unreviewed
- Consented and able to receive first HBOT session within first 48 hours of initiation of intravenous steroidsRegistry-derived · unreviewed
- Agreement to not participate in another trial for the duration of the active intervention periodRegistry-derived · unreviewed
Exclusion criteria (11)
- Received hyperbaric oxygen therapy either as part of standard of care or through a clinical trial prior to enrollmentRegistry-derived · unreviewed
- Complication requiring urgent surgical interventionRegistry-derived · unreviewed
- 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 randomizationRegistry-derived · unreviewed
- Toxic megacolonRegistry-derived · unreviewed
- Inability to receive intravenous steroidsRegistry-derived · unreviewed
- Historically failed or been exposed to 4 or more classes of advanced therapeutic optionsRegistry-derived · unreviewed
- Known or suspected diagnosis of Crohn's colitis, indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, microscopic colitis or infectious colitisRegistry-derived · unreviewed
- Received any investigational drug within 30 daysRegistry-derived · unreviewed
- Clinically significant cardiac, renal, neurological, endocrine, respiratory or hepatic impairment that increases the risk for HBOT toxicityRegistry-derived · unreviewed
- Women who are pregnant or nursingRegistry-derived · unreviewed
- Unwillingness to complete course of HBOTRegistry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
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 outcome
Clinical Response
Time frame: Day 3
Sum of Mayo rectal bleeding and stool frequency sub-scores (Key secondary endpoint)
Secondary outcome
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)
Secondary outcome
Endoscopic response
Time frame: Day 5
Ulcerative Colitis Endoscopic Index of Severity (UCEIS) (Key secondary endpoint)
Secondary outcome
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)
Secondary outcome
Endoscopic Improvement
Time frame: Day 90
Proportion of participants achieving endoscopic improvement (Mayo endoscopic sub-score of 0 or 1)
Secondary outcome
Endoscopic Remission
Time frame: Day 90
Proportion of participants achieving Endoscopic remission (Mayo endoscopic sub-score of 0)
Secondary outcome
Mucosal Healing
Time frame: Day 90
Proportion of participants achieving Mucosal Healing (Endoscopic sub-score 0 or 1 + Geboes histology score ≤ 2)
Secondary outcome
Clinical Remission
Time frame: Day 5
Proportion of participants achieving clinical remission (Full Mayo ≤ 2, with no sub-score \> 1)
Secondary outcome
Colectomy
Time frame: Day 90; 12 month
Proportion of participants requiring colectomy
Secondary outcome
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
Secondary outcome
Numeric Urgency Rating Score
Time frame: Day 3
Score ranges from 0-10 ; higher scores are worse
Secondary outcome
Serious Infections or Serious Adverse Events
Time frame: Day 5
Proportion of participants experiencing any serious infections or serious adverse events during intervention period
Recruiting locations in the United States
University of Alabama Medicine
RecruitingBirmingham, Alabama, 35233, United States
Kirk Russ, MDkruss@uabmc.edu
University of Los Angeles Health
RecruitingLos Angeles, California, 90024, United States
Jenny Sauk, MDjsauk@mednet.ucla.edu
University of Miami Health
RecruitingMiami, Florida, 33136, United States
Oriana Damas, MDomazorra@med.miami.edu
Orlando Health
RecruitingOrlando, Florida, 32806, United States
Udayakumar Navaneethan, MDudayakumar.navaneethan@orlandohealth.com
Northwestern Medicine Lake Forest Hospital
RecruitingLake Forest, Illinois, 60045, United States
Parambir S Dulai, MDparambir.dulai@northwestern.edu
University of Louisville
RecruitingLouisville, Kentucky, 40202, United States
Gerald Dryden, MDtad.dryden@louisville.edu
Massachusetts General Hospital
RecruitingBoston, Massachusetts, 02114, United States
Ashwin Ananthakrishnan, MDaananthakrishnan@mgh.harvard.edu
Mayo Clinic
RecruitingRochester, Minnesota, 55905, United States
Laura Raffals, MDraffals.laura@mayo.edu
Dartmouth Hitchcock Medical Center
RecruitingLebanon, New Hampshire, 03756, United States
Corey Siegel, MDcorey.a.siegel@hitchcock.org
Michael Winter, MDmichael.w.winter@hitchcock.org
State University of New York Upstate Medical University
RecruitingSyracuse, New York, 13210, United States
Idan Goren, MDGorenI@upstate.edu
Allegheny Health
RecruitingPittsburgh, Pennsylvania, 15090, United States
Aakash Desai, MDAakash.Desai@ahn.org
University of Pittsburgh Medical Center
RecruitingPittsburgh, Pennsylvania, 15213, United States
Jeffrey Dueker, MDduekerjm@upmc.edu
Central study contacts
Registry dates
- First posted
- Aug 14, 2023
- Primary completion
- Sep 1, 2027
- Overall completion
- Sep 1, 2027
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.