Exocrine Pancreatic Insufficiency Clinical Trials

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A Study to Determine the Prevalence of Exocrine Pancreatic Insufficiency (EPI) in Pediatric and Adult Participants With Alagille Syndrome After Liver Transplantation

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

The goal of this clinical trial is to determine the prevalence of exocrine pancreatic insufficiency (EPI) in a population of pediatric and adult participants with Alagille Syndrome (ALGS) post liver transplant. During the study, participants will: * Consume a high fat diet * Keep a diary of their abdominal signs and symptoms, and stool frequency and consistency * Collect stool for laboratory testing

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 50
Healthy Volunteers: f
View:

• Male and female participants ages 7-50 years inclusive.

• Confirmed diagnosis of ALGS

• Status post OLT due to ALGS complications.

• Participants currently managed with pancreatic enzyme products (PEPs) are allowed pending discontinuation of PEPs for 5 days prior to beginning the 72-hour stool collections. Participants must discontinue PEPs for the entire study period until completion.

• Agree to adhere to a high fat diet at least 2 days prior to and during the 72-hour stool collections and monitor dietary consumption through the use of a diet diary.

• Have a consistent caregiver for the duration of the study if applicable for enrollment of a child.

• Capable of giving written informed consent and assent (if age appropriate).

Locations
United States
Colorado
Children's Hospital Colorado - Research Institute
RECRUITING
Aurora
New York
Hassenfeld Children's Hospital at NYU Langone
NOT_YET_RECRUITING
New York
Ohio
Research Institute at Nationwide Children's Hospital
NOT_YET_RECRUITING
Columbus
Oregon
Oregon Health & Science University
NOT_YET_RECRUITING
Portland
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
Pediatric GI of El Paso
RECRUITING
El Paso
Washington
Seattle Children's Hospital - Research Institute
NOT_YET_RECRUITING
Seattle
Contact Information
Primary
Digestive Care Customer Service
customerservice@pertzye.com
877-882-5950
Time Frame
Start Date: 2026-08-03
Estimated Completion Date: 2028-08
Participants
Target number of participants: 30
Treatments
All Participants
Sponsors
Collaborators: Alagille Syndrome Alliance
Leads: Digestive Care, Inc.

This content was sourced from clinicaltrials.gov