Use of Pancreatic Enzymes in Short Bowel Syndrome (SBS)

• ClinicalTrials.gov Identifier: NCT03097029
• Recruitment Status: Completed
• First Posted: March 31, 2017
• Results First Posted: March 3, 2020
• Last Update Posted: March 20, 2020
• Sponsor: Children's Hospital of Philadelphia
• Collaborator: AbbVie
• Information provided by (Responsible Party): Children's Hospital of Philadelphia

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Short Bowel Syndrome	Drug: Pancreatic Enzyme	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Use of Pancreatic Enzymes in Short Bowel Syndrome
• Actual Study Start Date: March 24, 2017
• Actual Primary Completion Date: February 1, 2019
• Actual Study Completion Date: February 1, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Pancreatic Enzymes; All subjects in this study will have exposure to therapy with pancreatic enzymes for a period of about ten days.	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.; Other Name: Creon

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 Outcome Measures:

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.

Eligibility Criteria

• Ages Eligible for Study: 4 Years to 65 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Pennsylvania

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

Children's Hospital of Philadelphia

AbbVie

Investigators

• Principal Investigator: Natalie Terry, MD, PhD; Children's Hospital of Philadelphia

  Study Documents (Full-Text)

Documents provided by Children's Hospital of Philadelphia:

Study Protocol and Statistical Analysis Plan  [PDF] November 6, 2019

More Information

• Responsible Party: Children's Hospital of Philadelphia
• ClinicalTrials.gov Identifier: NCT03097029
• Other Study ID Numbers: 16-013255
• First Posted: March 31, 2017
• Results First Posted: March 3, 2020
• Last Update Posted: March 20, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Children's Hospital of Philadelphia:

pancreatic enzymes

Additional relevant MeSH terms:

Short Bowel Syndrome; Syndrome; Disease; Pathologic Processes; Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications