|- candidate number||17750|
|- NTR Number||NTR4640|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||15-mei-2014|
|- Secondary IDs||protocol ID NL45157.018.13|
|- Public Title||Research to the possible assciation between Chlamydia infection and the development of biliary atresia. |
|- Scientific Title||The Association between Chlamydia infection and Extrahepatic Biliairy Atresia, a case control study|
|- hypothesis||Previous or persisting infection with Chlamydia is associated with perinatal biliary atresia|
|- Healt Condition(s) or Problem(s) studied||Extrahepatic biliary obstruction, Chlamydia trachomatis|
|- 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
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||7-nov-2013|
|- planned closingdate||1-dec-2015|
|- Target number of participants||34|
|- Interventions||Mothers will undergo one venapuncture. Biliary atrsia patients and controls will not be exposed to extra interventions.|
|- 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.|
|- Timepoints||Aim is to complete inclusion within two years after strat date|
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD PhD-fellow Liesbeth Vries, de|
|- CONTACT for SCIENTIFIC QUERIES||MD PhD-fellow Liesbeth Vries, de|
|- Sponsor/Initiator |
(Source(s) of Monetary or Material Support)
|- Brief 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.
|- Main changes (audit trail)|
|- RECORD||15-mei-2014 - 24-jul-2014|