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

NCT07335523 | Not Yet Recruiting

• 1 other identifier: 102824-001
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Exocrine Pancreatic Insuficiency

Keywords

Alagille Syndrome; steatorrhea; liver transplant; fecal fat; coefficient of fat; exocrine pancreatic insufficiency

Outcome Measures

Primary Outcomes (1)

• Dietary fat absorption

  Dietary fat absorption is measured by calculating the percent of fat absorption (0-100%). Higher percentage of fat absorption indicates good fat absorption.

  At the completion of the 72-hour stool collection period

Study Arms (1)

All Participants

Diagnostic Test: Fecal Fat

Interventions

Fecal Fat DIAGNOSTIC_TEST

coefficient of fat absorption

All Participants

Eligibility Criteria

• Age: 7 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Male and female participants ages 7-50 years inclusive with a confirmed diagnosis of ALGS status post OLT due to ALGS complications.

You may qualify if:

• 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).

You may not qualify if:

• Surgical disruption of the enterohepatic circulation (e.g., biliary diversion).
• Subjects with alternative etiologies of EPI (e.g., chronic panreatitis, pancreatic resection).
• Diets high in medium-chain triglyceride (MCT) oil.
• Use of bile acids, bile acid uptake inhibitors, lipid-binding resins, synthetic fat substitutes (e.g. Olestra), and diaper rash ointments (note that H2 antagonists and proton pump inhibitors \[PPIs\] are permitted if on a stable and consistent regimen throughout the duration of the study).
• History or presence of other concomitant liver diseases such as liver transplant rejection with cholestasis, hepatitis B or C virus infection, HIV, primary sclerosing cholangitis (PSC), alcoholic liver disease, autoimmune hepatitis, metabolic-associated fatty liver disease (MASLD)/non-alcoholic steatohepatitis (NASH) or significant chronic allograft rejection.
• Currently pregnant or breastfeeding.
• Cancers except for in situ carcinoma or cancers treated at least 5 years prior to screening with no evidence of recurrence.
• Participation in a clinical trial and received an investigational product within the last 30 days.
• Use of anti-diarrheal, anti-spasmodic, and/or cathartic laxatives. Change in osmotic laxatives within the past 3 months.

Sponsors & Collaborators

• Digestive Care, Inc.: lead
• Alagille Syndrome Alliance: collaborator

MeSH Terms

Conditions

Alagille Syndrome; Steatorrhea; Exocrine Pancreatic Insufficiency

Condition Hierarchy (Ancestors)

Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Pancreatic Diseases

Central Study Contacts

Digestive Care Customer Service

CONTACT

877-882-5950; customerservice@pertzye.com

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 13, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share