Hyperbaric Oxygen for Ulcerative Colitis

NCT02144350 | Terminated Phase 2 DMC

• 1 other identifier: Broad-IBD-0372
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 3

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.

Conditions

Ulcerative Colitis

Keywords

hyperbaric oxygen

Outcome Measures

Primary Outcomes (1)

• Primary Response

  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.

  Day 5

Secondary Outcomes (3)

• Reduction in Full Mayo Score

  Day 10

• Reduction in Inflammatory Markers

  Day 10

• Progression to Second Line Therapy

  Day 10

Other Outcomes (1)

• Hyperbaric Oxygen Safety

  before and after hyperbaric oxygen treatments

Study Arms (2)

Intervention

EXPERIMENTAL

patients will undergo daily hyperbaric oxygen sessions in addition to IV steroids for 10 days.

Procedure: Hyperbaric oxygen

Sham

SHAM COMPARATOR

Patients will undergo sham hyperbaric air sessions in addition to IV steroids for 10 days

Procedure: Sham Hyperbaric Air

Interventions

Hyperbaric oxygen PROCEDURE

patients will be placed in a monoplane chamber and pressurized to 2.4 atmospheres with 100% oxygen for 90 minutes per session.

Intervention

Sham Hyperbaric Air PROCEDURE

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.

Sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Mayo Clinic: collaborator
• University of Pittsburgh: collaborator

Study Sites (3)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Corey A Siegel, MD, MS

  Dartmouth-Hitchcock Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Section Chief, Section of Gastroenterology

Study Record Dates

• First Submitted: May 13, 2014
• First Posted: May 22, 2014
• Study Start: August 1, 2013
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: April 6, 2018

Record last verified: 2016-11

Locations

US (3)