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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Digestive Care, Inc.
Study ID
NCT07335523
Status
Recruiting
Apply to this trial

Conditions

  • Exocrine Pancreatic Insuficiency

Eligibility Criteria

Sex
ALL
Age
7 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Fecal Fat — DIAGNOSTIC_TEST
    coefficient of fat absorption

Study Details

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

Key Dates

First listed
Jan 13, 2026
Start date
Aug 3, 2026
Status verified
Sep 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2028

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: All Participants

Primary Outcome Measure

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

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Children's Hospital Colorado - Research InstituteAuroraColorado80045
Study Coordinator
[email protected]
720-777-5705
Jacob Mark, MD (PRINCIPAL_INVESTIGATOR)
Hassenfeld Children's Hospital at NYU LangoneNew YorkNew York10016
Study Coordinator
[email protected]
(212) 263 5940
Dana Goldner, MD (PRINCIPAL_INVESTIGATOR)
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Principal Investigator
[email protected]
(513) 636-4200
Peter R Farrell, MD (PRINCIPAL_INVESTIGATOR)
Research Institute at Nationwide Children's HospitalColumbusOhio43205
Research Coordinator
[email protected]
614-722-2700
Alvin (Jay) Freeman, MD (PRINCIPAL_INVESTIGATOR)
Oregon Health & Science UniversityPortlandOregon97239
Research Coordinator
[email protected]
503-494-1078
Henry Lin, MD (PRINCIPAL_INVESTIGATOR)
Vanderbilt University Medical CenterNashvilleTennessee37232
Research Coordinator
[email protected]
615-343-2454
Saeed Mohammed, MD (PRINCIPAL_INVESTIGATOR)
Pediatric GI of El PasoEl PasoTexas79936
Study Coordinator
[email protected]
915-615-7005
Eduardo Rosas-Blum, MD (PRINCIPAL_INVESTIGATOR)
Seattle Children's Hospital - Research InstituteSeattleWashington98105
Clinical Research Coordinator
[email protected]
Evelyn Hsu, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Aurora, CO

By research site
Children's Hospital Colorado - Research Institute· Aurora, COHassenfeld Children's Hospital at NYU Langone· New York, NYCincinnati Children's Hospital Medical Center· Cincinnati, OHResearch Institute at Nationwide Children's Hospital· Columbus, OHOregon Health & Science University· Portland, ORVanderbilt University Medical Center· Nashville, TN