Clinical trial NCT05987852: Hyperbaric Oxygen Therapy for Ulcerative Colitis (HBOT-UC)
Official title: Hyperbaric Oxygen Therapy for Ulcerative Colitis Patients Hospitalized for Moderate to Severe Flares: a Multi-Center, Randomized, Double-Blind, Sham-Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ulcerative Colitis
Keywords: hyperbaric oxygen therapy
HBOT
ulcerative colitis
hyperbaric oxygen
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-08-14
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 5-day intervention period; 12 months observational period through standard of care visits and follow-up
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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
timeFrame: Day 5
Secondary outcomes:
measure: Clinical Response
timeFrame: Day 3
measure: Change in inflammation, as measured by C-reactive protein
timeFrame: Day 3
measure: Endoscopic response
timeFrame: Day 5
measure: Steroid-free, colectomy-free, clinical remission
timeFrame: Day 90
measure: Endoscopic Improvement
timeFrame: Day 90
measure: Endoscopic Remission
timeFrame: Day 90
measure: Mucosal Healing
timeFrame: Day 90
measure: Clinical Remission
timeFrame: Day 5
measure: Colectomy
timeFrame: Day 90; 12 month
measure: Re-hospitalization for ulcerative colitis flare
timeFrame: 12 months
measure: Numeric Urgency Rating Score
timeFrame: Day 3
measure: Serious Infections or Serious Adverse Events
timeFrame: Day 5
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Medicine
state: Alabama
city: Los Angeles
country: United States
facility: University of Los Angeles Health
state: California
city: Miami
country: United States
facility: University of Miami Health
state: Florida
city: Orlando
country: United States
facility: Orlando Health
state: Florida
city: Lake Forest
country: United States
facility: Northwestern Medicine Lake Forest Hospital
state: Illinois
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: New York
country: United States
facility: Cornell University Medical Center
state: New York
city: Syracuse
country: United States
facility: State University of New York Upstate Medical University
state: New York
city: Pittsburgh
country: United States
facility: Allegheny Health
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: Northwestern University
name: Lauren Balmert Bonner, PhD
role: PRINCIPAL_INVESTIGATOR
References: