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.
ID
Source
Brief title
Condition
- Hepatobiliary disorders congenital
Synonym
Research involving
Sponsors and support
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.
In case indications for DNA abnormalities will arise, the remainder of the
serum will be used for DNA analysis.
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
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.
Study 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 burden and risks
There will be no risk or burden for the children, who will undergo venapuncture
for follow-up purposes and will not have to undergo extra venapuncture for this
research. As biliary atresia is a disease of the young children, this study can
only be performed in this patient group. The mothers will have to undergo one
venapuncture, during which one tube of blood will be taken. Possible risk is
the occurrence of a haematoma as complication of the venapuncture, which is
regarded as a minor transient burden. No extra visits to the hospital are
necessary.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
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 then 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 |
|---|---|
| CCMO | NL45157.018.13 |