Intestinal Microbiome Composition in Infants With Biliary Atresia (BA)

Launched by CHILDREN'S HOSPITAL MEDICAL CENTER, CINCINNATI · Mar 24, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the gut bacteria (called the microbiome) in infants with biliary atresia, a condition that affects the liver and bile ducts, and comparing it to healthy infants. The researchers believe that babies with biliary atresia may have a different gut bacteria profile when they are diagnosed, and they want to see how this changes as the condition progresses. To do this, they will take samples of the gut bacteria at the time of diagnosis and at specific times later on.

To participate in this study, infants aged from birth to 5 months can be included if they have biliary atresia, certain other liver diseases, or if they are healthy controls with no liver issues. Parents or guardians will need to provide consent for their child to join the study. Participants won’t have to do anything different from their usual care, but they may be asked for samples of their stool to help researchers understand the differences in gut bacteria. It’s important to note that babies with severe organ failure or those who have been treated with antibiotics shortly before joining the study will not be eligible.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1. Age:
• • -Birth to 5 months
• • 2. Disease state: Must meet either (a), (b), or (c) for eligibility.
• a) Biliary atresia:
• • Conjugated hyperbilirubinemia (serum direct bilirubin \> 1mg/dL) AND demonstration of obstruction of extra hepatic bile ducts by examination of histological sections of extra hepatic bile ducts
• b) Neonatal cholestasis secondary to other causes of liver disease:
• • Diagnosis of liver disease caused by syndromes of intrahepatic cholestasis with or without hyperbilirubinemia
• c) Normal controls:
• • No acute or chronic liver related illness
• • 3. Signed informed consent/assent
• Exclusion Criteria:
• • 1. Evidence of multi-organ system failure (e.g. combined liver and kidney failure)
• • 2. For subjects \< 5 months old, treatment with antibiotics prior to enrollment into study