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Completed

NCT Number: NCT03097029

Use of Pancreatic Enzymes in Short Bowel Syndrome

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.

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Key information

Age range

4 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pancreatic Enzyme

Drug

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

Other names: Creon

Primary outcomes

  1. Change in Coefficient of Fat Absorption

    Time frame: 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 outcomes

  1. Change in the Coefficient of Nitrogen Absorption

    Time frame: 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.

Other outcomes

  1. Change in Malabsorption Blood Test

    Time frame: Up to 10 days

    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.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • AbbVie

Registry information

Acronym: SBS

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 31, 2017
Registry last updated
Mar 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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