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 9 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
- 9 sitesUnited States
- Study dates
- 3 Aug 2026to Aug 2028
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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.
Show all 9Show fewer
- 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
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 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
- Not yet recruiting
Medstar Georgetown Transplant Institute
Washington D.C., District of Columbia, 20007
Research Manager, 202-444-3514, jordan.s.babin@medstar.net
Udeme Ekong, 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
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Determine the Prevalence of Exocrine Pancreatic Insufficiency (EPI) in Pediatric and Adult Participants With Alagille Syndrome After Liver Transplantation
- ClinicalTrials.gov ID
- NCT07335523
- Acronym / sponsor ID
- 102824-001
- Conditions
- Exocrine Pancreatic Insuficiency
- Keywords
- Alagille Syndrome, steatorrhea, liver transplant, fecal fat, coefficient of fat, exocrine pancreatic insufficiency
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Digestive Care, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Alagille Syndrome Alliance
- Study start
- 3 Aug 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | Diagnostic Test: Fecal Fat |
Who may qualify
- Ages
- 7 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal Fatcoefficient of fat absorption | Diagnostic test | All Participants |
Primary outcome
Dietary fat absorption
Time frame: At the completion of the 72-hour stool collection period
Dietary fat absorption is measured by calculating the percent of fat absorption (0-100%). Higher percentage of fat absorption indicates good fat absorption.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exocrine Pancreatic Insuficiency, run by Digestive Care, Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Digestive Care Customer Service (877-882-5950, customerservice@pertzye.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dietary fat absorption (time frame: At the completion of the 72-hour stool collection period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.