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Evaluation of Immune Function in Biliary Atresia Children With Prolonged Jaundice

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ClinicalTrials.gov Identifier: NCT00155194
Recruitment Status : Unknown
Verified June 2005 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : September 12, 2005
Last Update Posted : September 12, 2005
Sponsor:
Information provided by:

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

Condition or disease
Biliary Atresia

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.

Study Design

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Impaired T-Lymphocyte Proliferative Function in Biliary Atresia Children With Prolonged Jaundice
Study Start Date : April 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00155194


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

Locations
Taiwan
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
Investigators
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
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: September 12, 2005
Last Verified: June 2005

Additional relevant MeSH terms:
Jaundice
Biliary Atresia
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Digestive System Abnormalities
Congenital Abnormalities