Evaluation of Immune Function in Biliary Atresia Children With Prolonged Jaundice

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2005 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
First received: September 9, 2005
Last updated: NA
Last verified: June 2005
History: No changes posted
Null hypothesis of this study: Biliary atresia patients with cholestatic jaundice do not have systemic immunity defect.

Biliary Atresia

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Official Title: Impaired T-Lymphocyte Proliferative Function in Biliary Atresia Children With Prolonged Jaundice

Resource links provided by NLM:

Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment: 30
Study Start Date: April 2004
Detailed 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.

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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).

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00155194

Contact: Jia-Feng Wu, MD 886-2-23123456 ext 5451 water@ha.mc.ntu.edu.tw

Department of Pediatrics, National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Yen-Hsuan Ni, MD    886-2-23123456 ext 5451    yhni@ha.mc.ntu.edu.tw   
Contact: Jia-Feng Wu, MD    886-2-23123456 ext 5451    water@ha.mc.ntu.edu.tw   
Principal Investigator: Jia-Feng Wu, MD         
Sponsors and Collaborators
National Taiwan University Hospital
Study Chair: Mei-Hwei Chang, MD Department of Pediatrics, Natonal Taiwan University Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00155194     History of Changes
Other Study ID Numbers: 9361701170 
Study First Received: September 9, 2005
Last Updated: September 9, 2005
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Biliary Atresia
Bile Duct Diseases
Biliary Tract Diseases
Congenital Abnormalities
Digestive System Abnormalities
Digestive System Diseases

ClinicalTrials.gov processed this record on May 26, 2016