Hyperbaric Oxygen for Ulcerative Colitis

• ClinicalTrials.gov Identifier: NCT02144350
• Recruitment Status: Terminated
• First Posted: May 22, 2014
• Last Update Posted: April 6, 2018
• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: Mayo Clinic; University of Pittsburgh
• Information provided by (Responsible Party): Corey Siegel, Dartmouth-Hitchcock Medical Center

Tracking Information

• First Submitted Date: May 13, 2014
• First Posted Date: May 22, 2014
• Last Update Posted Date: April 6, 2018
• Study Start Date: August 2013
• Actual Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 19, 2014)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 19, 2014)

• 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
• 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
• 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

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: May 19, 2014)

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.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Hyperbaric Oxygen for Ulcerative Colitis
• Official Title: Hyperbaric Oxygen Therapy for Moderate to Severe Ulcerative Colitis Flares: A Multi-center Randomized Double Blind Sham Controlled Trial
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Ulcerative Colitis

Intervention

• 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.
• 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.

Study Arms

• Experimental: Intervention
  patients will undergo daily hyperbaric oxygen sessions in addition to IV steroids for 10 days.
  Intervention: Procedure: Hyperbaric oxygen
• Sham Comparator: Sham
  Patients will undergo sham hyperbaric air sessions in addition to IV steroids for 10 days
  Intervention: Procedure: Sham Hyperbaric Air

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: November 30, 2016): 18
• Original Estimated Enrollment (submitted: May 19, 2014): 77
• Actual Study Completion Date: November 2016
• Actual Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02144350
• Other Study ID Numbers: Broad-IBD-0372
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Corey Siegel, Dartmouth-Hitchcock Medical Center
• Original Responsible Party: Dartmouth-Hitchcock Medical Center
• Current Study Sponsor: Dartmouth-Hitchcock Medical Center
• Original Study Sponsor: Same as current

Collaborators

• Mayo Clinic
• University of Pittsburgh

Investigators

• Study Director: Corey A Siegel, MD, MS; Dartmouth-Hitchcock Medical Center

• PRS Account: Dartmouth-Hitchcock Medical Center
• Verification Date: November 2016