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Recruiting NCT07335523

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

Conditions: Exocrine Pancreatic Insuficiency

Sex: All
Ages: 7 Years – 50 Years
Healthy volunteers: No
Enrollment: 30
Sponsor: Digestive Care, Inc.

Location: Children's Hospital Colorado - Research Institute Aurora Colorado

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 Criteria

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 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). Exclusion Criteria: * 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07335523). StuddyBuddy aggregates publicly available trial information.