Hyperbaric Oxygen Therapy for Ulcerative Colitis Flares

Description

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 (1, 2). 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% (3). 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 (4, 5). 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 (6, 7). 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 (8, 9). 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 Start Date

September, 07 2017

Estimated Completion Date

March 2019

Interventions

  • Other: Hyperbaric Oxygen Therapy

Study ID

Dartmouth-Hitchcock Medical Center -- Broad-IBD-HBO-UC D12161

Status

Unknown

Trial ID

NCT03494764

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

30

Sponsor

Dartmouth-Hitchcock Medical Center

Inclusion Criteria

    1. Hospitalized patients with known or newly diagnosed moderate to severe ulcerative colitis (as defined by the Mayo score ?6) with the additional following criteria: 1. Consented within the first 48 hours of initiating IV steroids 2. Risk score of >3 points (pts)
  • Mean stool frequency/24 hrs (<4 = 0 pts, 4-6 = 1 pt, 7-9 = 2 pts, >9 = 4 pts)
  • Colonic Dilation = 4pts
  • Hypoalbuminemia (< 3mg/dL) = 1 pts 2. Mayo endoscopic sub-score >2 (moderate to severe) 3. Age >18 and able to make their own medical decisions

Exclusion Criteria

  • 1. Complication requiring urgent surgical intervention (in the opinion of the investigators) 2. Clinically significant cardiac, renal, neurological, endocrine, respiratory or hepatic impairment in the opinion of the investigator, including but not limited to: a. 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) b. 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 c. Hematological/Oncological i. Current chemotherapeutic drug use, and past history of bleomycin use. ii. Hereditary Spherocytosis iii. Sickle cell anemia d. Gastrointestinal and Infectious Disease i. Known or suspected Crohn's disease ii. Previous infection with mycobacterium, fungus, HIV, Hepatitis B or C iii. Severe gastrointestinal or systemic infection (opinion of investigator) iv. Current capsule endoscopy or previously non-retrieved capsule e. Endocrinology i. Uncontrolled hyperthyroidism f. Neurological and Psychological i. Vagal or other nerve stimulators ii. Uncontrolled seizure disorder iii. Medications or medical conditions that lower seizure threshold (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 g. Head and Neck i. Previous middle ear damage, surgery or infection(s) which may increase the risk for needing ear tubes (opinion of the investigator) ii. Current or previous retinal detachment or optic neuritis iii. Retinal or vitreous surgery within the past 3 months h. Miscellaneous i. Implanted devices not on the approved list for use with HBOT 3. 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.

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (6)

Study Location Distance Name Phone Email
DartmouthHitchcock Medical Center - Lebanon, New Hampshire 106.0 miles laurie Skinner 603-653-3651 laurie.a.skinner@hitchcock.org
University of Pittsburgh - Pittsburgh, Pennsylvania 478.1 miles Kim GoldbyReffner 412-648-9173 goldbyreffnerka@upmc.edu
Mayo Clinic - Rochester, Minnesota 1,083.1 miles Jessica Friton 507-538-0678 Friton.jessica@mayo.edu
University of Texas Southwestern Medical Center - Dallas, Texas 1,543.9 miles Shan UdoUtan 214-648-9647 shan.udo-utan@UTSouthwestern.edu
Virginia Mason Memorial Hospital - Yakima, Washington 2,420.0 miles Sarah Ackermann 206-341-1295 sarah.ackermann@virginiamason.org
University of California San Diego - San Diego, California 2,582.6 miles Christina Chickering 858-246-2544 cendrigachickering@mail.ucsd.edu

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