A Study to Determine the Prevalence of Exocrine Pancreatic Insufficiency (EPI) in Pediatric and Adult Participants With Alagille Syndrome After Liver Transplantation
Digestive Care, Inc.
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
- Age range
- 7–50 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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…
Interventions
- Diagnostic TestFecal Fat
coefficient of fat absorption
Locations (2)
- Children's Hospital Colorado - Research InstituteAurora, Colorado
- Pediatric GI of El PasoEl Paso, Texas