NCT03097029

Use of Pancreatic Enzymes in Short Bowel Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 4 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Short Bowel Syndrome

Interventions

Type	Name	Description
DRUG	Pancreatic Enzyme	All subjects will take pancreatic enzymes at a dose appropriate for their weight. Pancreatic enzymes are used to help digest fat and other nutrients.

Timeline

• Start date: 2017-03-24
• Primary completion: 2019-02-01
• Completion: 2019-02-01
• First posted: 2017-03-31
• Last updated: 2020-03-20
• Results posted: 2020-03-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study