Use of Pancreatic Enzymes in Short Bowel Syndrome



Status:Completed
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:4 - 65
Updated:3/27/2019
Start Date:March 24, 2017
End Date:February 1, 2019

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Patients with short bowel syndrome have a high mortality rate that is mainly attributed to
complications from central lines and long-term intravenous (IV) nutrition. There are few
medical therapies to date that improve gut absorption in patients with short bowel syndrome.
The primary objective of this study is to evaluate if absorption from the GI tract improves
in subjects with short bowel syndrome following therapy with pancreatic enzymes.

This is an interventional study of subjects with short bowel syndrome to determine if enteral
absorption improves following therapy with pancreatic enzymes. The study will assess enteral
absorption and nutritional status at baseline through a series of stool tests, blood tests,
and anthropometric measurements. Following approximately ten days of therapy with pancreatic
enzymes, the study will reassess enteral absorption.

Inclusion Criteria:

- history of a small bowel resection with subsequent dependence on parenteral nutrition
for at least three months

- age 4 years to 65 years

- usual state of health for the past two weeks with no medication changes

- able to participate in a study for about four weeks with four study visits

- able to take pancreatic enzyme medication orally

Exclusion Criteria:

- significant disease other than short bowel syndrome affecting the gastrointestinal
tract that impacts absorption or digestions

- motility disorder

- medications that directly alter fat absorption

- cholestatic liver disease defined as a serum conjugated bilirubin greater than 1.0
mg/dL, chronic renal failure, gout, or hyperuricemia

- history of a pork allergy

- women who are pregnant or lactating

- history of fibrosing colonopathy

Those subjects who are eligible for the malabsorption blood test (MBT) test will be
excluded if they have a history of a soy or safflower oil allergy.
We found this trial at
1
site
South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Principal Investigator: Natalie Terry, MD, PhD
Phone: 215-713-7939
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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