Database for Biliary Atresia

(PROBE Trial)

Recruiting at 10 trial locations

Overseen By Melissa Sexton, BBA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Arbor Research Collaborative for Health

Disqualifiers: Acute liver failure, Previous surgery, Sepsis, Hypoxia, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to gather information and samples from infants with cholestasis, a condition where bile flow from the liver is blocked, causing jaundice (yellowing of the skin). The focus is on understanding and improving treatments for conditions like biliary atresia and neonatal hepatitis, which affect liver function in newborns. Infants who are 180 days old or younger and have been diagnosed with cholestasis qualify as good candidates for this trial. The goal is to build a database to help researchers develop better treatments for these serious liver diseases in children. As an unphased trial, this study offers participants a unique opportunity to contribute to groundbreaking research that could lead to significant advancements in treating liver diseases in infants.

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to gather comprehensive data on infants with cholestasis, which is crucial for understanding this condition better. Unlike existing treatments that primarily focus on managing symptoms, this trial seeks to identify underlying factors and patterns in infant cholestasis. By creating a detailed database, researchers hope to uncover new insights that could lead to more effective and targeted treatments in the future. This approach could significantly improve outcomes for affected infants by paving the way for innovative therapies.

Who Is on the Research Team?

Katrina Loh, MD

Principal Investigator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Saul Karpen, MD, PhD

Principal Investigator

VCU School of Medicine

Ed Doo, MD

Principal Investigator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Lisa Henn, PhD

Principal Investigator

Arbor Research Collaborative for Health

John Magee, MD

Principal Investigator

University of Michigan Medical Center, Ann Arbor

Are You a Good Fit for This Trial?

Inclusion Criteria

Infant's age less than or equal to 180 days at initial presentation at the ChiLDREN clinical site.

Diagnosis of cholestasis defined by serum direct or conjugated bilirubin greater than 20% of total and greater than or equal to 2 mg/dl.

The subject's parent(s)/guardian(s) willing to provide informed written consent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

At presentation

1 visit (in-person)

Initial Follow-up

Participants diagnosed with BA are followed intensively for the first year

12 months

Multiple visits (in-person)

Long-term Follow-up

Participants are monitored annually up to 20 years of age or until liver transplantation

Up to 20 years

Annual visits (in-person)

Data Collection and Sample Repository

Collection of clinical data and biological samples for research purposes

What Are the Treatments Tested in This Trial?

Who Is Running the Clinical Trial?

Arbor Research Collaborative for Health

Lead Sponsor

Trials

21

Recruited

35,500+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+