RECRUITING

Hyperbaric Oxygen Therapy for Ulcerative Colitis

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Conditions

Ulcerative Colitishyperbaric oxygen therapyHBOThyperbaric oxygen

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-01-09
Study Completion:2027-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05987852

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants with known or newly diagnosed UC who require hospitalization for an acute moderate to severe flare
  2. * Age 18-85
  3. * Consented and able to receive first HBOT session within first 48 hours of initiation of intravenous steroids
  1. * Complication requiring urgent surgical intervention
  2. * Toxic megacolon
  3. * Inability to receive intravenous steroids
  4. * Historically failed 3 or more classes of advanced therapeutic options
  5. * Known or suspected diagnosis of Crohn's colitis, indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, microscopic colitis or infectious colitis
  6. * Received any investigational drug within 30 days
  7. * Clinically significant cardiac, renal, neurological, endocrine, respiratory or hepatic impairment that increases the risk for HBOT toxicity
  8. * Women who are pregnant or nursing
  9. * Unwillingness to complete course of HBOT
  10. * Active SARS CoV 2 infection

Contacts and Locations

Study Contact

Yasmin Pina, BS
CONTACT
312-503-6459
yasmin.pina@northwestern.edu
Mary Beth Tull, MS
CONTACT
312-503-4746
mary.tull@northwestern.edu

Principal Investigator

Lauren Balmert Bonner, PhD
PRINCIPAL_INVESTIGATOR
Northwestern University

Study Locations (Sites)

University of Alabama Medicine
Birmingham, Alabama, 35233
United States
University of Los Angeles Health
Los Angeles, California, 90024
United States
University of Miami Health
Miami, Florida, 33136
United States
Orlando Health
Orlando, Florida, 32806
United States
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045
United States
University of Louisville
Louisville, Kentucky, 40202
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
United States
Cornell University Medical Center
New York, New York, 10065
United States
State University of New York Upstate Medical University
Syracuse, New York, 13210
United States
Allegheny Health
Pittsburgh, Pennsylvania, 15090
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
United States
University of Virginia Health
Charlottesville, Virginia, 22903
United States

Collaborators and Investigators

Sponsor: Northwestern University

  • Lauren Balmert Bonner, PhD, PRINCIPAL_INVESTIGATOR, Northwestern University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-09
Study Completion Date2027-09-01

Study Record Updates

Study Start Date2024-01-09
Study Completion Date2027-09-01

Terms related to this study

Keywords Provided by Researchers

  • hyperbaric oxygen therapy
  • HBOT
  • ulcerative colitis
  • hyperbaric oxygen

Additional Relevant MeSH Terms

  • Ulcerative Colitis