Influence of fatty acid metabolism for clinical course of biliary atresia

JRCT ID: jRCTs041180088

Registered date:12/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: biliary atresia, neonatal hepatitis, Alagille syndrome, PFIC, etc.
• Date of first enrollment: 01/12/2016
• Target sample size: 30
• Study type: Interventional
• Intervention(s): oral administration of 30(+/- 10)mg/kg/day of eicosapentaenoic acid

Outcome(s)

• Primary Outcome: Liver fibrosis in BA patients with or without administration of EPA
• Secondary Outcome: The difference of concentration of long chain polyunsaturated fatty acids, or eicosanoids among BA group and non-BA groups

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both
• Include criteria: 1) New case with biliary atresia. 2) As control group A, cases of suspected biliary atresia with liver dysfunction or jaundice. 3) As control group B, healthy individuals with similar age.
• Exclude criteria: A history of blood transfusion within 1 month before enrollment

Related Information

• Primary Sponsor: Sumida Wataru
• Secondary Sponsor: Uchida Hiroo