Back to results

Use of Pancreatic Enzymes in Short Bowel Syndrome (SBS)

Primary Purpose

Short Bowel Syndrome

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Pancreatic Enzyme

About this trial

This is an interventional treatment trial for Short Bowel Syndrome focused on measuring pancreatic enzymes

Eligibility Criteria

4 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Children's Hospital of Philadelphia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pancreatic Enzymes

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03097029

First Posted

March 24, 2017

Last Updated

March 9, 2020

Sponsor

Children's Hospital of Philadelphia

Collaborators

AbbVie

1. Study Identification

Unique Protocol Identification Number

NCT03097029

Brief Title

Use of Pancreatic Enzymes in Short Bowel Syndrome

Acronym

SBS

Official Title

Use of Pancreatic Enzymes in Short Bowel Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

March 24, 2017 (Actual)

Primary Completion Date

February 1, 2019 (Actual)

Study Completion Date

February 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Children's Hospital of Philadelphia

Collaborators

AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Short Bowel Syndrome

Keywords

pancreatic enzymes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pancreatic Enzymes

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Pancreatic Enzyme

Other Intervention Name(s)

Creon

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Coefficient of Fat Absorption

Description

Time Frame

Up to 10 days

Secondary Outcome Measure Information:

Title

Change in the Coefficient of Nitrogen Absorption

Description

Time Frame

Up to 10 days

Other Pre-specified Outcome Measures:

Title

Change in Malabsorption Blood Test

Description

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.

Time Frame

Up to 10 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Natalie Terry, MD, PhD

Organizational Affiliation

Children's Hospital of Philadelphia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Children's Hospital of Philadelphia

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35622082

Citation

Sainath NN, Bales C, Brownell JN, Pickett-Blakely O, Sattar A, Stallings VA. Impact of Pancreatic Enzymes on Enteral Fat and Nitrogen Absorption in Short Bowel Syndrome. J Pediatr Gastroenterol Nutr. 2022 Jul 1;75(1):36-41. doi: 10.1097/MPG.0000000000003465. Epub 2022 May 27.

Results Reference

derived

Learn more about this trial

Use of Pancreatic Enzymes in Short Bowel Syndrome

We'll reach out to this number within 24 hrs