30 Participants NeededMy employer runs this trial

Pancreatic Insufficiency for Alagille Syndrome

Recruiting at 6 trial locations
DC
Overseen ByDigestive Care Customer Service
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are You a Good Fit for This Trial?

This trial is for children and adults aged 7-50 who have Alagille Syndrome, have had a liver transplant because of it, and show signs of fat in their stool. Participants must be able to stop taking pancreatic enzyme pills before and during the study, follow a high-fat diet, and keep track of symptoms.

Inclusion Criteria

I have been diagnosed with Alagille syndrome.
I agree to follow a high fat diet and keep a food diary for specific days.
I am between 7 and 50 years old.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dietary Intervention

Participants consume a high fat diet and keep a diary of their abdominal signs and symptoms, and stool frequency and consistency

72 hours
1 visit (in-person) for stool collection

Follow-up

Participants are monitored for safety and effectiveness after the dietary intervention

4 weeks

What Are the Treatments Tested in This Trial?

Trial Overview

The study checks how common pancreatic insufficiency is after liver transplant in people with Alagille Syndrome by having them eat a high-fat diet, record digestive symptoms, and collect stool samples for lab testing.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: All ParticipantsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Digestive Care, Inc.

Lead Sponsor

Trials
6
Recruited
100+

Alagille Syndrome Alliance

Collaborator

Trials
1
Recruited
40+