Hyperbaric Oxygen Therapy for Ulcerative Colitis Flares

• Register: ClinicalTrials.gov
• Last refreshed on: 16 February 2021
• Main ID: NCT03494764
• Date of registration: 04/04/2018
• Prospective Registration: No
• Primary sponsor: Dartmouth-Hitchcock Medical Center
• Public title: Hyperbaric Oxygen Therapy for Ulcerative Colitis Flares HBO-UC
• Scientific title: Hyperbaric Oxygen Therapy for Moderate to Severe Ulcerative Colitis Flares: A Multi-Center Randomized Trial
• Date of first enrolment: September 7, 2017
• Target sample size: 39
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03494764
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Parambir Dulai, MD
• Affiliation: University of California, San Diego

Key inclusion & exclusion criteria

Inclusion Criteria:

- Hospitalized patients with known or newly diagnosed moderate to severe ulcerative
colitis (as defined by the Mayo score =6)

- Consented within the first 48 hours of initiating IV steroids

- Risk score of >3 points (pts)

- Mean stool frequency/24 hrs (<4 = 0 pts, 4-6 = 1 pt, 7-9 = 2 pts, >9 = 4 pts)

- Colonic Dilation = 4pts

- Hypoalbuminemia (< 3mg/dL) = 1 pts

- Mayo endoscopic sub-score >2 (moderate to severe)

- Age >18 and able to make their own medical decisions

Exclusion Criteria:

- Complication requiring urgent surgical intervention (in the opinion of the
investigators)

- Clinically significant cardiac, renal, neurological, endocrine, respiratory or hepatic
impairment in the opinion of the investigator, including but not limited to:

- Pulmonary (COPD with CO2 retention; Previous/current imaging showing
hyperinflation/air trapping/bullous disease/blebs (opinion of investigators),
Current pneumothorax or previous spontaneous pneumothorax, Bronchogenic cyst(s))

- Cardiac (Uncontrolled HTN (systolic >160 or diastolic >100), Unstable angina or
myocardial infarction within the previous 3 months, Ejection fraction < 35%,
Current or previous amiodarone use, ICD in place, Pacemaker in place not approved
for chamber use)

- Hematological/Oncological (Current chemotherapeutic drug use, and past history of
bleomycin use,Hereditary Spherocytosis, Sickle cell anemia)

- Gastrointestinal and Infectious Disease (Known or suspected Crohn's disease,
Previous infection with mycobacterium, fungus, HIV, Hepatitis B or C, Severe
gastrointestinal or systemic infection (opinion of investigator), Current capsule
endoscopy or previously non-retrieved capsule

- Endocrinology (Uncontrolled hyperthyroidism)

- Neurological and Psychological (Vagal or other nerve stimulators, Uncontrolled
seizure disorder, Medications or medical conditions that lower seizure threshold
(opinion of the investigator), Drug or alcohol abuse/dependence,Current treatment
for alcohol cessation with disulfiram, Current or recent (within past week) use
of baclofen)

- Head and Neck (Previous middle ear damage, surgery or infection(s) which may
increase the risk for needing ear tubes (opinion of the investigator),Current or
previous retinal detachment or optic neuritis, Retinal or vitreous surgery within
the past 3 months)

- Implanted devices not on the approved list for use with HBOT

- Women who are pregnant or nursing. Women with childbearing potential were required to
use effective birth control if not surgically sterile or postmenopausal for >2 years.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Colitis, Ulcerative

Intervention(s)

Other: Hyperbaric Oxygen Therapy

Primary Outcome(s)

Impact of HBOT on clinical response/remission [Time Frame: 5 Days]

Secondary Outcome(s)

Hospitalization duration [Time Frame: day5, 10]

Flair duration [Time Frame: day 5, 10]

microbiome composition [Time Frame: day 10]

proportion of patients requiring other therapy [Time Frame: Day 5, 10]

Relative and absolute change in inflammatory markers [Time Frame: day 10]

relative and absolute reduction in the Mayo score [Time Frame: Day 5, 10]

Relative and absolute change in gene expression [Time Frame: day 10]

Secondary ID(s)

Broad-IBD-HBO-UC D12161

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Pittsburgh Medical Center

Foundation for Clinical Research in IBD

University of Texas Southwestern Medical Center

NYU Langone Health

The Eli and Edythe Broad Foundation

University of Maryland, College Park

Virginia Mason Memorial Hospital

University of California, San Diego

Mayo Clinic