New study to reveal hidden pancreatic issues in alagille syndrome patients after transplant
NCT ID NCT07335523
First seen Jun 25, 2026 · Last updated Sep 21, 2026 · Updated 7 times
Summary
This study aims to find out how often exocrine pancreatic insufficiency (EPI) occurs in people with Alagille syndrome who have had a liver transplant. About 30 participants aged 7 to 50 will eat a high-fat diet and collect stool samples for lab testing. The results will help doctors better understand and manage digestive health in this group.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If this study succeeds, it could help doctors understand how often EPI occurs in Alagille syndrome patients after a liver transplant, leading to better diagnosis and care.
- What could go wrong
- This is a small, early observational study with only 30 participants, so results may not apply to everyone. It does not test a new treatment, so it won't directly improve health.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Male and female participants ages 7-50 years inclusive with a confirmed diagnosis of ALGS status post OLT due to ALGS complications.
- Ages
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7 to 50 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
8 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Children's Hospital Colorado - Research Institute
RECRUITINGAurora, Colorado, 80045, United States
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Cincinnati Children's Hospital Medical Center
NOT_YET_RECRUITINGCincinnati, Ohio, 45229, United States
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Hassenfeld Children's Hospital at NYU Langone
RECRUITINGNew York, New York, 10016, United States
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Oregon Health & Science University
NOT_YET_RECRUITINGPortland, Oregon, 97239, United States
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Pediatric GI of El Paso
RECRUITINGEl Paso, Texas, 79936, United States
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Research Institute at Nationwide Children's Hospital
NOT_YET_RECRUITINGColumbus, Ohio, 43205, United States
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Seattle Children's Hospital - Research Institute
NOT_YET_RECRUITINGSeattle, Washington, 98105, United States
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Vanderbilt University Medical Center
RECRUITINGNashville, Tennessee, 37232, United States