ClinicalTrials.gg
RecruitingNCT07335523Updated Oct 27, 2026

Determine the Prevalence of Exocrine Pancreatic Insufficiency (EPI) in Pediatric and Adult Participants With Alagille Syndrome After Liver Transplantation

An observational study in Exocrine Pancreatic Insuficiency, sponsored by Digestive Care, Inc.. Recruiting at 9 sites in United States. Open to participants aged 7 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Digestive Care, Inc. · Observational

From the registry’s dates

  • Started Aug 2026; still recruiting 3 months later.
Updated Oct 27, 2026Site recruiting status changed1 site addedGo to Updates ↓
Study type
Observational
Model
Ecologic or community
Time perspective
Prospective
Enrollment
30
Ages
7 Years to 50 Years
Sex
All
01

Study 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
02

Conditions studied

  • Exocrine Pancreatic Insuficiency

Keywords

  • Alagille Syndrome
  • steatorrhea
  • liver transplant
  • fecal fat
  • coefficient of fat
  • exocrine pancreatic insufficiency
03

In context

Alagille Syndrome

31 studies on the registry are indexed under Alagille Syndrome; 11 are open to participants now.

This study's planned enrollment of 30 is below the median of 120 across 15 observational studies indexed under Alagille Syndrome.

Browse Alagille Syndrome studies →

Lead sponsor

Digestive Care, Inc. is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Male and female participants ages 7-50 years inclusive with a confirmed diagnosis of ALGS status post OLT due to ALGS complications.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 and assent (if age appropriate).

Exclusion criteria

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, or C virus infection, , primary sclerosing cholangitis (PSC), alcoholic liver disease, 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 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.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
30 participants (estimated)
Target follow-up
1 Week
Patient registry
Yes

Groups and cohorts

  • All Participants

    Diagnostic Test: Fecal Fat

Interventions

  • Diagnostic testFecal Fat

    coefficient of fat absorption

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At the completion of the 72-hour stool collection period

07

Study locations

5 of 9 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2026 (actual). Primary completion is estimated for Aug 2027, 12 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 8, 2026
First posted
Jan 13, 2026
StartActual
Aug 3, 2026
Primary completionEst.
Aug 2027
CompletionEst.
Aug 2028
Last update
Oct 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
1 site added. Seattle Children's Hospital - Research Institute is now Recruiting
Show site
  • Medstar Georgetown Transplant Institute · Washington D.C., United States
across 2 updates, Oct 13, 2026 – Oct 27, 2026
Show all 2 updates
  1. Oct 27, 2026
    1 site added
    Show site
    • Medstar Georgetown Transplant Institute · Washington D.C., United States
  2. Oct 13, 2026
    Seattle Children's Hospital - Research Institute is now Recruiting
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07335523
Lead sponsor
Digestive Care, Inc.
Collaborators
Alagille Syndrome Alliance
Responsible party
Sponsor
First posted
Jan 13, 2026
Start date
Aug 3, 2026
Primary completion
Aug 2027 (estimated)
Completion
Aug 2028 (estimated)
Last update
Oct 27, 2026

Study contacts

Digestive Care Customer Service
Contact
customerservice@pertzye.com
877-882-5950

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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