Hyperbaric Oxygen Therapy for Ulcerative Colitis Flares

Status:	Recruiting
Conditions:	Colitis, Colitis, Gastrointestinal
Therapuetic Areas:	Gastroenterology
Healthy:	No
Age Range:	18 - Any
Updated:	3/28/2019
Start Date:	September 7, 2017
End Date:	September 1, 2019
Contact:	Kim Thompson, MS
Email:	kimberly.d.thompson@hitchock.org
Phone:	860-287-2714

Hyperbaric Oxygen Therapy for Moderate to Severe Ulcerative Colitis Flares: A Multi-Center Randomized Trial

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.

Inclusion Criteria:

- Hospitalized patients with known or newly diagnosed moderate to severe ulcerative
colitis (as defined by the Mayo score ≥6)

- Consented within the first 48 hours of initiating IV steroids

- 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

- Mayo endoscopic sub-score >2 (moderate to severe)

- Age >18 and able to make their own medical decisions

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 (COPD with CO2 retention; Previous/current imaging showing
hyperinflation/air trapping/bullous disease/blebs (opinion of investigators),
Current pneumothorax or previous spontaneous pneumothorax, Bronchogenic cyst(s))

- Cardiac (Uncontrolled HTN (systolic >160 or diastolic >100), Unstable angina or
myocardial infarction within the previous 3 months, Ejection fraction < 35%,
Current or previous amiodarone use, ICD in place, Pacemaker in place not approved
for chamber use)

- Hematological/Oncological (Current chemotherapeutic drug use, and past history of
bleomycin use,Hereditary Spherocytosis, Sickle cell anemia)

- Gastrointestinal and Infectious Disease (Known or suspected Crohn's disease,
Previous infection with mycobacterium, fungus, HIV, Hepatitis B or C, Severe
gastrointestinal or systemic infection (opinion of investigator), Current capsule
endoscopy or previously non-retrieved capsule

- Endocrinology (Uncontrolled hyperthyroidism)

- Neurological and Psychological (Vagal or other nerve stimulators, Uncontrolled
seizure disorder, Medications or medical conditions that lower seizure threshold
(opinion of the investigator), Drug or alcohol abuse/dependence,Current treatment
for alcohol cessation with disulfiram, Current or recent (within past week) use
of baclofen)

- Head and Neck (Previous middle ear damage, surgery or infection(s) which may
increase the risk for needing ear tubes (opinion of the investigator),Current or
previous retinal detachment or optic neuritis, Retinal or vitreous surgery within
the past 3 months)

- 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.

We found this trial at

sites

The Mayo Clinic

Rochester, Minnesota 55905

Principal Investigator: Laura Raffals, MD

Phone: 507-538-0678

from

Rochester, MN