Ulcerative colitis (UC) is a chronic inflammatory bowel disease associated with recurrent mucosal inflammation. Clinically, the disease is characterized by bloody diarrhea, abdominal pain, and constitutional symptoms such as fever and weight loss. Treatment strategies vary based on disease activity and target various aspects of the inflammatory cascade. Options include: anti-inflammatory drugs (mesalamine), immunosuppressive or modulatory medications (corticosteroids, thiopurines, cyclosporine) and biologic agents (Anti-TNF). Disease severity can be wide ranging, and nearly 25% of UC patients are hospitalized for acute severe disease. Of these patients, 30% will undergo colectomy after the acute episode, a quarter of which will experience post-operative complications. Although there has been great progress in treatment of UC over the past decade, even with the anti-TNF agent infliximab, the one-year remission rate for patients not responding to conservative management is barely 20%. Furthermore, corticosteroids have significant long-term consequences and immune suppressive drugs such as 6-mercaptopurine, azathioprine and infliximab have been associated with serious adverse events including life-threatening infections and lymphomas. With growing evidence that the pathogenesis of UC is multi-factorial and involves a complex interaction of genetic and environmental factors, newer treatment modalities are being evaluated to target the mucosal immune response and mucosal inflammatory regulatory system. Hyperbaric oxygen offers a promising new treatment option since it targets both tissue hypoxia and inflammation. Recent small scales studies evaluating the impact of hyperbaric oxygen treatment in acute ulcerative colitis flares demonstrated improved outcomes. The mechanisms underlying the improvement are not known. In this study, we will treat ulcerative colitis flares with hyperbaric oxygen and measure changes in both markers of tissue hypoxia and inflammation. We hypothesize that hyperbaric oxygen will (a) improve outcomes, and (b) show reductions in markers of both tissue hypoxia and inflammation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Hyperbaric oxygen (HBO) provides 100% oxygen at a pressure above atmospheric pressure (typically twice to three times standard sea level pressure (2.0-3.0 ATA)). This dramatically increases the amount of oxygen dissolved in blood plasma, which in turn increases oxygen delivery to tissues. This effect of hyperbaric oxygen is used clinically to treat acute hypoxia in crush injuries, severed limbs, and failing skin grafts
UC San Diego Health Systems
La Jolla, California, United States
University of California San Diego
San Diego, California, United States
University of Maryland
Baltimore, Maryland, United States
Mayo Clinic
Rochester, Minnesota, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
NYU Langone Medical Center
New York, New York, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Virginia Mason Memorial Hospital
Yakima, Washington, United States
Impact of HBOT on clinical response/remission
Impact of HBOT on clinical response/remission to medical therapy as measured by the partial Mayo score at study day 5.
Time frame: 5 Days
relative and absolute reduction in the Mayo score
Relative and absolute reduction in the Mayo score
Time frame: Day 5, 10
Flair duration
time to reduction in mayo score
Time frame: day 5, 10
Hospitalization duration
time in the hospital
Time frame: day5, 10
proportion of patients requiring other therapy
Proportion who require cyclosporine, infliximab or colectomy during index flare
Time frame: Day 5, 10
Relative and absolute change in inflammatory markers
Relative absolute change in inflammatory markers: ESR
Time frame: day 10
Relative and absolute change in inflammatory markers
Relative absolute change in inflammatory markers: CRP
Time frame: day 10
Relative and absolute change in inflammatory markers
Relative absolute change in inflammatory markers: fecal calprotectin
Time frame: day 10
Relative and absolute change in inflammatory markers
Relative absolute change in inflammatory markers: interleukins
Time frame: day 10
Relative and absolute change in gene expression
Relative absolute change in gene expression: VEGF
Time frame: day 10
Relative and absolute change in gene expression
Relative absolute change in gene expression: HIF-1
Time frame: day 10
Relative and absolute change in gene expression
Relative absolute change in gene expression: HO-1
Time frame: day 10
microbiome composition
Describe the HBOT specific changes in the microbiome composition
Time frame: day 10
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