Understanding Biliary Atresia in Children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to gather clinical information, genetic material, and body fluid samples from children diagnosed with biliary atresia (BA) to explore the causes and progression of the disease. It focuses on identifying genetic defects and autoimmune factors that may contribute to BA and its complications. The study also seeks to characterize the natural history of older children with BA, examining how sentinel events like variceal bleeding and growth failure may predict outcomes such as liver transplantation or mortality. By comparing these children to healthy controls, the study aims to enhance understanding of the disease's impact on quality of life.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participants need to have a confirmed diagnosis of BA determined by chart review including review of pertinent diagnostic biopsy reports, radiologic reports and surgical reports (if surgery was performed).
2. Participants need to be \>6 months of age up to and equal to the age of 20 (participants enrolled at 20 years of age will have one visit).
3. Participants with their native liver.
4. Parent, guardian or participant (if 18 years of age or older) is willing to provide informed consent and, when appropriate, the participant is willing to assent.

Exclusion Criteria:

1. Currently participating in the ChiLDReN study PROBE.
2. Inability to confirm original diagnostic evaluation of biliary atresia.
3. Inability or unwillingness of family or participant to participate in all scheduled visits.
4. History of liver transplantation.

Where it's running

• Children's Hospital of Los Angeles
  Los Angeles, California, United States Recruiting
• Children's Hospital Colorado
  Aurora, Colorado, United States Recruiting
• Children's Healthcare of Atlanta - Emory University
  Atlanta, Georgia, United States Recruiting
• Ann & Robert H. Lurie Children's Hospital of Chicago
  Chicago, Illinois, United States Recruiting
• Children's Hospital Medical Center
  Cincinnati, Ohio, United States Recruiting
• Children's Hospital of Philadelphia
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: John C Magee, MD — University of Michigan
• Study coordinator: Melissa Sexton, BBA, CCRP
• Email: melissa.sexton@arborresearch.org
• Phone: 734-693-3811

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Using oral antibiotics to prevent cholangitis after liver surgery in infants

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.