Evaluation of Immune Function in Biliary Atresia Children With Prolonged Jaundice

Biliary Atresia Clinical Trial

Official title:

Impaired T-Lymphocyte Proliferative Function in Biliary Atresia Children With Prolonged Jaundice

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00155194
• Other study ID #: 9361701170
• Status: Recruiting
• Phase: N/A
• First received: September 9, 2005
• Last updated: September 9, 2005
• Start date: April 2004

Study information

• Verified date: June 2005
• Source: National Taiwan University Hospital
• Contact: Jia-Feng Wu, MD
• Phone: 886-2-23123456
• Email: water[@]ha.mc.ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

Null hypothesis of this study: Biliary atresia patients with cholestatic jaundice do not have systemic immunity defect.

Description:

Biliary atresia patients with cholestatic jaundice were noted to have increased incidence of infectious complications. Previous animal models of bile duct ligation with acute jaundice ever demonstrated impairment of both humoral and cellular immune function. We performed the immunity study in biliary atresia patients due to the lack of comprehensive systemic immunity study in pediatric cholestatic model. Systemic humoral immunity (total serum IgG, IgA, IgM, C3 and C4), specific cellular immunity (lymphocyte classification, mitogen response, cytokines level after PHA stimulation test), and non-specific cellular immunity (absolute neutrophil count, PMN CD11b/CD18 expression level, PMN superoxide release function, and PMN phagocytosis function) were tested. Association with serum bilirubin level, nutritional status and blood biochemical values were tested to see the relation between systemic immune function and cholestatic jaundice.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year and older

Eligibility

Inclusion Criteria:

Biliary patients older than 1-year-old status post Kasai operation.

Exclusion Criteria:

Received liver transplantation, immunosuppresant, systemic immunoglobulin (within 6 months) and obvious infectious episode (within 2 weeks).

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Biliary Atresia

Locations

Country	Name	City	State
Taiwan	Department of Pediatrics, National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan,