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Hyperbaric Oxygen for Ulcerative Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02144350
Recruitment Status : Terminated (slow recruitment)
First Posted : May 22, 2014
Last Update Posted : April 6, 2018
Sponsor:
Collaborators:
Mayo Clinic
University of Pittsburgh
Information provided by (Responsible Party):
Corey Siegel, Dartmouth-Hitchcock Medical Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Procedure: Hyperbaric oxygen Procedure: Sham Hyperbaric Air Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hyperbaric Oxygen Therapy for Moderate to Severe Ulcerative Colitis Flares: A Multi-center Randomized Double Blind Sham Controlled Trial
Study Start Date : August 2013
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention
patients will undergo daily hyperbaric oxygen sessions in addition to IV steroids for 10 days.
 Procedure: Hyperbaric oxygen
patients will be placed in a monoplane chamber and pressurized to 2.4 atmospheres with 100% oxygen for 90 minutes per session.
Sham Comparator: Sham
Patients will undergo sham hyperbaric air sessions in addition to IV steroids for 10 days
 Procedure: Sham Hyperbaric Air
Patients will undergo a brief compression to 1.34 atmospheres with room air and then they will be brought back to 1.1 atmospheres to complete a 90 minute session.


Outcome Measures
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Primary Outcome Measures :
  1. Primary Response [ Time Frame: Day 5 ]
    Impact of hyperbaric oxygen therapy on clinical response/remission to medical therapy as measured by the partial Mayo score at study day 5. Clinical remission will be defined as a partial Mayo score of less than or equal to 2 with no individual sub-score exceeding 1 point. Clinical response will be defined as a decrease in partial Mayo score greater than or equal to 2 points with a decrease in rectal bleeding sub-score of greater than or equal to 1 point, or an absolute rectal bleeding sub-score of 0 or 1.


Secondary Outcome Measures :
  1. Reduction in Full Mayo Score [ Time Frame: Day 10 ]
    We will compare the % and absolute reduction in the full Mayo score at study day 10 between the intervention and sham control group

  2. Reduction in Inflammatory Markers [ Time Frame: Day 10 ]
    We will compare the % and absolute reduction in the CRP and ESR at study days 3, 5 and 10 between the intervention and sham control group

  3. Progression to Second Line Therapy [ Time Frame: Day 10 ]
    We will compare the proportion of patients requiring infliximab, cyclosporine or colectomy during hospitalization between the intervention and sham control group


Other Outcome Measures:
  1. Hyperbaric Oxygen Safety [ Time Frame: before and after hyperbaric oxygen treatments ]
    The rate of barotrauma, seizures, or claustrophobia with hyperbaric oxygen therapy will be monitored to ensure there are no safety concerns with this intervention. Patients will be assessed before and after each treatment session for any complications related to hyperbaric oxygen therapy. This will be done daily until all 10 treatments are completed.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 i. COPD with CO2 retention; Previous/current imaging showing hyperinflation/air trapping/bullous disease/blebs (opinion of investigators) ii. Current pneumothorax or previous spontaneous pneumothorax iii. Bronchogenic cyst(s)
  • Cardiac i. Uncontrolled HTN (systolic >160 or diastolic >100) ii. Unstable angina or myocardial infarction within the previous 3 months iii. Ejection fraction < 35% iv. Current or previous amiodarone use v. ICD in place vi. Pacemaker in place not approved for chamber use
  • Hematological/Oncological i. Current chemotherapeutic drug use, and past history of bleomycin use. ii. Hereditary Spherocytosis iii. Sickle cell anemia
  • Gastrointestinal and Infectious Disease i. Known or suspected Crohn's disease ii. Previous infection with mycobacterium, fungus, HIV, Hepatitis B or C iii. Gastrointestinal or systemic infection including, but not limited to, --Clostridium difficile iv. Current capsule endoscopy or previously non-retrieved capsule Endocrinology i. Uncontrolled hyperthyroidism

Neurological and Psychological i. Vagal or other nerve stimulators

ii. Uncontrolled seizure disorder

iii. Medications or medical conditions that lower seizure threshold (in the opinion of the investigator) iv. Drug or alcohol abuse/dependence v. Current treatment for alcohol cessation with disulfiram vi. Current or recent (within past week) use of baclofen Head and Neck i. Previous middle ear damage, surgery or infection(s) which may increase the risk for needing ear tubes (in the opinion of the investigator) ii. Current or previous retinal detachment or optic neuritis iii. Retinal or vitreous surgery within the past 3 months Miscellaneous i. 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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02144350


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15261
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Mayo Clinic
University of Pittsburgh
Investigators
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Study Director: Corey A Siegel, MD, MS Dartmouth-Hitchcock Medical Center
More Information
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Responsible Party: Corey Siegel, Section Chief, Section of Gastroenterology, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT02144350    
Other Study ID Numbers: Broad-IBD-0372
First Posted: May 22, 2014    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: November 2016
Keywords provided by Corey Siegel, Dartmouth-Hitchcock Medical Center:
hyperbaric oxygen
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases