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History of Changes for Study: NCT02144350
Hyperbaric Oxygen for Ulcerative Colitis
Latest version (submitted April 4, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 19, 2014 None (earliest Version on record)
2 December 17, 2014 Study Status
3 June 11, 2015 Study Status and Contacts/Locations
4 January 7, 2016 Study Status and Contacts/Locations
5 March 4, 2016 Contacts/Locations and Study Status
6 October 27, 2016 Study Status
7 November 30, 2016 Recruitment Status, Study Status, Contacts/Locations and Study Design
8 April 4, 2018 Sponsor/Collaborators and Study Status
Comparison Format:

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Study NCT02144350
Submitted Date:  May 19, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: Broad-IBD-0372
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
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2014
Overall Status: Recruiting
Study Start: August 2013
Primary Completion: July 2015 [Anticipated]
Study Completion: July 2016 [Anticipated]
First Submitted: May 13, 2014
First Submitted that
Met QC Criteria:
May 19, 2014
First Posted: May 22, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
May 19, 2014
Last Update Posted: May 22, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Dartmouth-Hitchcock Medical Center
Responsible Party: Sponsor
Collaborators: Mayo Clinic
University of Pittsburgh
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Ulcerative Colitis
Keywords: hyperbaric oxygen
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2/Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 77 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
Open or close this module Outcome Measures
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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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.

Open or close this module Contacts/Locations
Central Contact Person: Parambir Dulai, MD
Telephone: (408)431-0377
Email: parambir.s.dulai@gmail.com
Study Officials: Corey A Siegel, MD, MS
Study Director
Dartmouth-Hitchcock Medical Center
Locations: United States, Minnesota
Mayo Clinic
[Active, not recruiting]
Rochester, Minnesota, United States, 55905
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
[Recruiting]
Lebanon, New Hampshire, United States, 03756
Contact:Contact: Corey Siegel, MD 603-650-5325 corey.a.siegel@hitchcock.org
Contact:Principal Investigator: Corey A Siegel, MD, MS
United States, Pennsylvania
University of Pittsburgh
[Active, not recruiting]
Pittsburgh, Pennsylvania, United States, 15261
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
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Links:
Available IPD/Information:

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