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Evaluation of Immune Function in Biliary Atresia Children With Prolonged Jaundice

NCT ID: NCT00155194

Last Updated: 2005-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Biliary Atresia

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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).
Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Mei-Hwei Chang, MD

Role: STUDY_CHAIR

Department of Pediatrics, Natonal Taiwan University Hospital

Locations

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Department of Pediatrics, National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Jia-Feng Wu, MD

Role: CONTACT

Phone: 886-2-23123456

Email: [email protected]

Facility Contacts

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Yen-Hsuan Ni, MD

Role: primary

Jia-Feng Wu, MD

Role: backup

Other Identifiers

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9361701170

Identifier Type: -

Identifier Source: org_study_id