Hyperbaric Oxygen for Ulcerative Colitis
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 13-008673
NCT ID: NCT02144350
Sponsor Protocol Number: HBO-UC
About this study
The investigators aim to prospectively study the feasibility and clinical impact of hyperbaric oxygen therapy in acute hospitalized moderate to severe ulcerative colitis flares as an adjunct to standard medical treatment. Specifically, we will investigate the impact of hyperbaric oxygen therapy on clinical response/remission and serum and mucosal inflammatory markers. The investigators expect that hyperbaric oxygen therapy will improve patient responsiveness to steroids and avoid progression to second line therapy during hospitalization.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Laura Raffals, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available