Use of Pancreatic Enzymes in Short Bowel Syndrome

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-24

Study Completion Date

2019-02-01

Brief Summary

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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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Detailed Description

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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

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Short Bowel Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pancreatic Enzymes

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

Group Type EXPERIMENTAL

Pancreatic Enzyme

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Creon

Eligibility Criteria

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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.

Minimum Eligible Age

4 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No