Recruiting

Observational Study

Sponsor:

Digestive Care, Inc.

Code:

NCT07335523

Conditions

Exocrine Pancreatic Insuficiency

Eligibility Criteria

Sex: All

Age: 7 - 50

Healthy Volunteers: Not accepted

Interventions

Fecal Fat

Study Details

Brief 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

Conditions

Exocrine Pancreatic Insuficiency

Study ID

NCT07335523

Start date

Aug 3, 2026

Status verified date

Aug, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 50

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

All Participants

Interventions

Fecal Fat

coefficient of fat absorption

Primary outcome measure

  • Dietary fat absorption [ Time Frame: At the completion of the 72-hour stool collection period ]

Central Contacts and Locations

Central contacts

Digestive Care Customer Service

877-882-5950customerservice@pertzye.com

Locations

Children's Hospital Colorado - Research Institute

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Study Coordinator

720-777-5705Cynthia.Castanon@childrenscolorado.org

Principal Investigator:

Jacob Mark, MD

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Research Coordinator

615-343-2454addison.c.francis@vumc.org

Principal Investigator:

Saeed Mohammed, MD

Pediatric GI of El Paso

Recruiting

El Paso, Texas, United States, 79936

Contacts

Study Coordinator

915-615-7005helengtz@elppedsgi.com

Principal Investigator:

Eduardo Rosas-Blum, MD

More Information

Sponsor

Digestive Care, Inc.

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Digestive Care, Inc. on 2026-09-01.