Use of Pancreatic Enzymes in Short Bowel Syndrome

Phase 2

Completed

Conditions: Short Bowel Syndrome

Interventions: Drug: Pancreatic Enzyme

Registration Number: NCT03097029

Lead Sponsor: Children's Hospital of Philadelphia

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 16

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pancreatic Enzymes	Pancreatic Enzyme	All subjects in this study will have exposure to therapy with pancreatic enzymes for a period of about ten days.

Primary Outcome Measures

Name	Time	Method
Change in Coefficient of Fat Absorption	Up to 10 days	Coefficient of fat absorption (CFA) measures the amount of fat excreted in the stool compared to how much fat was consumed over the course of 72 hours. This is a measure of fat absorption. CFA was measured at baseline off of pancreatic enzymes and then again while on ten days of pancreatic enzyme supplementation. The change between CFA values at each timepoint was the primary outcome.

Secondary Outcome Measures

Name	Time	Method
Change in the Coefficient of Nitrogen Absorption	Up to 10 days	Coefficient of nitrogen absorption (CNA) measures the amount of nitrogen excreted in the stool compared to how much nitrogen was consumed in a 72 hour period. This is a measure of protein absorption. CNA was measured at baseline off of pancreatic enzymes and then again while on ten days of pancreatic enzyme supplementation. The change between CNA values at each timepoint was a study outcome.