Hyperbaric Oxygen for Ulcerative Colitis
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|ClinicalTrials.gov Identifier: NCT02144350|
Recruitment Status : Terminated (slow recruitment)
First Posted : May 22, 2014
Last Update Posted : April 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Procedure: Hyperbaric oxygen Procedure: Sham Hyperbaric Air||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
- 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.
- 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
- 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.
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
|United States, Minnesota|
|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|
|Study Director:||Corey A Siegel, MD, MS||Dartmouth-Hitchcock Medical Center|