No registrations found.
ID
Source
Brief title
Health condition
Extrahepatic Biliary Atresia, Chlamydia infection
Sponsors and support
Department of Gastroenterology and Hepatology
Academic Medical Center
The Netherlands
Department of Gastroenterology and Hepatology
Academic Medical Center
The Netherlands
Intervention
Outcome measures
Primary outcome
The presence of Chlamydia IgA antibody in serum of Dutch patients with biliary atresia, compared to the control group. The presence of Chlamydia in liver tissue (liver biopsy and fibrotic remnant obtained during Kasai operation) of BA patients as compared to controls, examined by PCR as well as Chlamydia-specific staining by immunohistochemistry.
Secondary outcome
The presence of Chlamydia IgA antibody in serum of mothers of patients with biliary atresia, compared to the presence of Chlamydia IgA antibody in serum of mothers of the control group and the presence of Chlamydia IgA antibody in the general population.
Background summary
Rationale: The aetiology of perinatal biliary atresia is unknown, but the cause is probably multifactorial. Even though many viruses have been described as possible causative agents for biliary atresia, there are little data about the association between bacterial microorganism and biliary atresia.
Chlamydia infection could lead to the chronic inflammation and obliteration of bile ducts by the induction of an antibody response against heat shock protein 60. In a cohort of English patients we found a significant higher prevalence of Chlamydia antibodies in serum of children with biliary atresia compared to controls.
Objective: To confirm that previous or persisting infection with Chlamydia is associated with the development of perinatal biliary atresia.
Furthermore to investigate whether the Chlamydia infection is contracted by vertical transmission from the mothers.
Study design: Multicentre centre case control study.
Study population: 19 patients younger than 12 years with biopsy proven biliary atresia, who are monitored at the outpatient clinic and their mothers, controlled by 15 patients younger than 12 years with hepatoblastoma, who are monitored at the outpatient clinic and their mothers.
Main study parameters/endpoints: The presence of Chlamydia IgA antibodies in serum, PCR and immunohistochemistry for Chlamydia in liver tissue of children diagnosed with biliary atresia, as well as the presence of Chlamydia IgA antibodies in the serum of their mothers.
Study objective
Previous or persisting infection with Chlamydia is associated with perinatal biliary atresia
Study design
Aim is to complete inclusion within two years after strat date
Intervention
Mothers will undergo one venapuncture. Biliary atrsia patients and controls will not be exposed to extra interventions.
Dept. of Gastroenterology and Hepatology Academic Medical Center Amsterdam
Room C2-310
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31-205668091
e.m.g.devries@amc.uva.nl
Dept. of Gastroenterology and Hepatology Academic Medical Center Amsterdam
Room C2-310
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31-205668091
e.m.g.devries@amc.uva.nl
Inclusion criteria
• Biopsy proven biliary atresia
• Underwent Kasai operation
• Liver tissue stored at the Department of Pathology
• Outpatient follow up in the Academic Medical Center, Amsterdam or University Medical Centre Groningen
• Younger than 12 years
•Informed consent of custodial parent(s) or guardian, for inclusion of their child
• Informed consent of the mother for the withdrawal of maternal blood for ELISA on Chlamydia
Exclusion criteria
• Patients with embryonic biliary atresia
• Older then 12 years
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL4136 |
NTR-old | NTR4640 |
Other | NL45157.018.13 : protocol ID |