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Evaluation of Immune Function in Biliary Atresia Children With Prolonged Jaundice

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2005 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00155194
First Posted: September 12, 2005
Last Update Posted: September 12, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Taiwan University Hospital
  Purpose
Null hypothesis of this study: Biliary atresia patients with cholestatic jaundice do not have systemic immunity defect.

Condition
Biliary Atresia

Study Type: Observational
Study Design: 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

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.
  Eligibility

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 Submitted: September 9, 2005
First Posted: September 12, 2005
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