Exocrine Pancreatic InsuficiencyNCT07335523
Determine the Prevalence of Exocrine Pancreatic Insufficiency (EPI) in Pediatric and Adult Participants With Alagille Syndrome After Liver Transplantation
An observational study of Exocrine Pancreatic Insuficiency, run by Digestive Care, Inc. at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 50 years
- Conditions the study is for
- Exocrine Pancreatic Insuficiency
- What is being tested?
- Fecal Fat
- How many people
- 30 participants
- Where
- 8 sitesUnited States
- Study dates
- 3 Aug 2026to Aug 2028
- How long will I take part?
- 1 Week
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Male and female participants ages 7-50 years inclusive with a confirmed diagnosis of ALGS status post OLT due to ALGS complications.
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Children's Hospital Colorado - Research Institute
Aurora, Colorado, 80045
Study Coordinator, 720-777-5705, Cynthia.Castanon@childrenscolorado.org
Jacob Mark, MD
- Not yet recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Principal Investigator, (513) 636-4200, peter.farrell@cchmc.org
Peter R Farrell, MD
- Not yet recruiting
Research Institute at Nationwide Children's Hospital
Columbus, Ohio, 43205
Research Coordinator, 614-722-2700, Divya.Srirambhatla@nationwidechildrens.org
Alvin (Jay) Freeman, MD
- Recruiting
Pediatric GI of El Paso
El Paso, Texas, 79936
Study Coordinator, 915-615-7005, helengtz@elppedsgi.com
Eduardo Rosas-Blum, MD
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Research Coordinator, 615-343-2454, addison.c.francis@vumc.org
Saeed Mohammed, MD
- Recruiting
Hassenfeld Children's Hospital at NYU Langone
New York, New York, 10016
Study Coordinator, (212) 263 5940, aamina.ahmed@nyulangone.org
Dana Goldner, MD
- Not yet recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Research Coordinator, 503-494-1078, royde@ohsu.edu
Henry Lin, MD
- Recruiting
Seattle Children's Hospital - Research Institute
Seattle, Washington, 98105
Clinical Research Coordinator, Teresa.Chen@seattlechildrens.org
Evelyn Hsu, MD
About this study
Official title: A Study to Determine the Prevalence of Exocrine Pancreatic Insufficiency (EPI) in Pediatric and Adult Participants With Alagille Syndrome After Liver Transplantation
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
- Being tested
- Fecal Fat
- Keywords
- Alagille Syndrome, steatorrhea, liver transplant, fecal fat, coefficient of fat, exocrine pancreatic insufficiency
- Medical subject headings
- Alagille Syndrome, Steatorrhea, Exocrine Pancreatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal FatDiagnostic test
coefficient of fat absorption
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Not described Receives: Diagnostic Test: Fecal Fat |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the completion of the 72-hour stool collection period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start3 Aug 2026
- Primary completionAug 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exocrine Pancreatic InsuficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Digestive Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alagille Syndrome Alliance
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07335523
- Sponsor's protocol ID
- 102824-001
- Status last verified
- Oct 2026
- First submitted
- 8 Jan 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No