Use of Pancreatic Enzymes in Short Bowel Syndrome

Short Bowel Syndrome Clinical Trial

— SBS  

Official title:

Use of Pancreatic Enzymes in Short Bowel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03097029
• Other study ID #: 16-013255
• Status: Completed
• Phase: Phase 2
• Start date: March 24, 2017
• Est. completion date: February 1, 2019

Study information

• Verified date: March 2020
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: February 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Short Bowel Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Malabsorption Blood Test	This test will only be performed on subjects 18 years or older. This an isotope test. Subjects consume a high fat shake with two labeled fats. They have blood tests measured at baseline and then every 1 hour for 8 hours to check for serum levels of labeled fats. This helps determine how well the labeled fats are being absorbed by the intestine.	Up to 10 days
Primary	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	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