Status:
NOT_YET_RECRUITING
Stool Card in Biliary Atresia
Lead Sponsor:
Assiut University
Conditions:
Stool Color Card
Biliary Atresia
Eligibility:
All Genders
1-90 years
Brief Summary
To evaluate the effectiveness of using a stool color card as a non-invasive screening tool for the early detection of biliary atresia, with the objective of improving early diagnosis rates and facilit...
Detailed Description
Biliary atresia (BA) is a rare but life-threatening liver disorder that affects infants, characterized by the progressive inflammation and fibrosis of the bile ducts, leading to biliary obstruction \[...
Eligibility Criteria
Inclusion
- Neonates and infants aged 1-90 days old.
- Neonates and infants with direct (conjugated) hyperbilirubinemia (Conjugated hyperbilirubinemia is generally defined as a conjugated or direct bilirubin level greater than 1 mg/dL when the total bilirubin is less than 5 mg/dL or more than 20% of the total bilirubin if the total bilirubin is greater than 5 mg/dL) \[12\]
- No contraindication for liver biopsy as considered the gold standard for diagnosis of biliary atresia e.g. coagulopathy.
Exclusion
- 1 - Infants diagnosed with biliary atresia or other cholestatic liver diseases prior to enrollment.
- 2-Infants aged more than 90 days 3-Neonates and infants with indirect hyperbilirubinemia. 4-Those with contraindication to do liver biopsy
Key Trial Info
Start Date :
September 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07139717
Start Date
September 1 2025
End Date
December 1 2026
Last Update
August 24 2025
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