Use of Pancreatic Enzymes in Short Bowel Syndrome (SBS)

Children's Hospital of Philadelphia (CHOP)

Status and phase: Completed; Phase 2

Conditions: Short Bowel Syndrome

Treatments: Drug: Pancreatic Enzyme

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03097029

16-013255

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 4 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Pancreatic Enzymes

Experimental group

Description:

All subjects in this study will have exposure to therapy with pancreatic enzymes for a period of about ten days.

Treatment:

Drug: Pancreatic Enzyme