Clinical trial NCT03097029: Use of Pancreatic Enzymes in Short Bowel Syndrome
Official title: Use of Pancreatic Enzymes in Short Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Short Bowel Syndrome
Keywords: pancreatic enzymes
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: AbbVie
First posted: 2017-03-31
Enrollment: 16
Sex: ALL
Minimum age (years): 4
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Coefficient of Fat Absorption
timeFrame: Up to 10 days
Secondary outcomes:
measure: Change in the Coefficient of Nitrogen Absorption
timeFrame: Up to 10 days
Other outcomes:
measure: Change in Malabsorption Blood Test
timeFrame: Up to 10 days
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Natalie Terry, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.