A Study to Determine the Prevalence of Exocrine Pancreatic Insufficiency (EPI) in Pediatric and Adult Participants With Alagille Syndrome After Liver Transplantation
| Registry | NCT07335523 |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Enrollment | 30 (Estimated) |
| Sponsor | Digestive Care, Inc. (Industry); collaborators: Alagille Syndrome Alliance |
| Conditions | Exocrine Pancreatic Insuficiency |
| Interventions | Fecal Fat (Diagnostic test) |
| Dates | start 2026-08-03, primary completion 2027-08-01 (estimated), completion 2028-08-01 (estimated), first posted 2026-01-13, last updated 2026-10-13 |
| Locations | 8 sites in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Exocrine Pancreatic Insuficiency All trials of Fecal Fat
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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| All Participants | Diagnostic Test: Fecal Fat |
Sex: All, ages: 7 Years to 50 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Children's Hospital Colorado - Research Institute | Aurora, Colorado | United States | Recruiting |
| Hassenfeld Children's Hospital at NYU Langone | New York, New York | United States | Recruiting |
| Cincinnati Children's Hospital Medical Center | Cincinnati, Ohio | United States | Not yet recruiting |
| Research Institute at Nationwide Children's Hospital | Columbus, Ohio | United States | Not yet recruiting |
| Oregon Health & Science University | Portland, Oregon | United States | Not yet recruiting |
| Vanderbilt University Medical Center | Nashville, Tennessee | United States | Recruiting |
| Pediatric GI of El Paso | El Paso, Texas | United States | Recruiting |
| Seattle Children's Hospital - Research Institute | Seattle, Washington | United States | Recruiting |