Clinical Trial

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

Recruiting
View on ClinicalTrials.gov →
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
Protocol Amendment History 8 changes
critical Recruitment opened 2026-08-08
notable Primary completion pushed: 2027-05 -> 2027-08 2026-08-08
minor Completion pushed: 2028-05 -> 2028-08 2026-08-08
critical Phase changed: not applicable -> not specified 2026-05-01
critical Phase changed: Phase 2 -> not applicable 2026-04-23
critical Primary endpoint(s) modified 2026-04-23
notable Primary completion pushed: 2027-03 -> 2027-05 2026-04-23
minor Completion pushed: 2028-03 -> 2028-05 2026-04-23
Trial Details
NCT Number NCT07335523
Lead Sponsor Digestive Care, Inc.
Collaborators: Alagille Syndrome Alliance
Conditions Exocrine Pancreatic Insuficiency
Enrollment 30 participants
Start Date 2026-08-03
Primary Completion 2027-08 (estimated)
Study Completion 2028-08 (estimated)
Updated on ClinicalTrials.gov 2026-08-07