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