Evaluation of Immune Function in Biliary Atresia Children With Prolonged Jaundice

September 9, 2005 updated by: National Taiwan University Hospital

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

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

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Recruiting
        • Department of Pediatrics, National Taiwan University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jia-Feng Wu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Study Chair: Mei-Hwei Chang, MD, Department of Pediatrics, Natonal Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

September 12, 2005

Last Update Submitted That Met QC Criteria

September 9, 2005

Last Verified

June 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9361701170

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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