Ensayos clínicos

Inclusion Criteria:

• known or newly diagnosed moderate to severe ulcerative colitis with a Mayo score of greater than 6
• Mayo endoscopic sub-score of greater than or equal to 2
• Risk score of greater than or equal to 4 points

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
    • Gastrointestinal or systemic infection including, but not limited to, --Clostridium difficile
    • 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 (in the 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 (in the opinion of the investigator)
    • Current or previous retinal detachment or optic neuritis
    • Retinal or vitreous surgery within the past 3 months
  • Miscellaneous
    • 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.