NCT03097029

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

March 24, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 31, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

March 3, 2020

Completed
Last Updated

March 20, 2020

Status Verified

March 1, 2020

Enrollment Period

1.9 years

First QC Date

March 24, 2017

Results QC Date

January 21, 2020

Last Update Submit

March 9, 2020

Conditions

Short Bowel Syndrome

Keywords

pancreatic enzymes

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 10 days

Secondary Outcomes (1)

  • Change in the Coefficient of Nitrogen Absorption

    Up to 10 days

Other Outcomes (1)

  • Change in Malabsorption Blood Test

    Up to 10 days

Study Arms (1)

Pancreatic Enzymes

EXPERIMENTAL

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

Drug: Pancreatic Enzyme

Interventions

Pancreatic EnzymeDRUG

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

Also known as: Creon
Pancreatic Enzymes

Eligibility Criteria

Age4 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • 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.

    PMID: 35622082DERIVED

MeSH Terms

Conditions

Short Bowel Syndrome

Interventions

Pancrelipase

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LipaseCarboxylic Ester HydrolasesEsterasesHydrolasesEnzymesEnzymes and CoenzymesPancreatic ExtractsTissue ExtractsComplex Mixtures

Results Point of Contact

Title
Dr. Nina Sainath
Organization
Children's Hospital of Philadelphia
sainathn@email.chop.edu
267.426.1736

Study Officials

  • Natalie Terry, MD, PhD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2017

First Posted

March 31, 2017

Study Start

March 24, 2017

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

March 20, 2020

Results First Posted

March 3, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)