Use of Pancreatic Enzymes in Short Bowel Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Use of Pancreatic Enzymes in Short Bowel Syndrome

Conditions
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Short Bowel Syndrome

Intervention / Treatment
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* Drug: Pancreatic Enzyme


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pancreatic Enzymes<br>All subjects in this study will have exposure to therapy with pancreatic enzymes for a period of about ten days. | Drug: Pancreatic Enzyme<br>* All subjects will take pancreatic enzymes at a dose appropriate for their weight. Pancreatic enzymes are used to help digest fat and other nutrients.<br>* Other names: Creon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Coefficient of Fat Absorption | 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. | Up to 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Coefficient of Nitrogen Absorption | 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. | Up to 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreatic enzymes