Gut Microbiome in Biliary Atresia

Study Overview
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Brief Summary
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The investigator will investigate the gut-microbiome and liver elasticity of the Biliary Atresia (BA)-patients before and after Kasai operation. The data will be analyzed according to their clinical outcomes including cholangitis to find out diagnostic makers, significantly associated with the BA-phenotypes. The decision-making tree for the BA will be updated with our data, which will strength the prognosis and prediction. The establishment of gut-liver axis, featured by cholangitis and gut-microbiome will open new pathway to treat the BA using fecal microbiota transplantation. Analysis of gut-microbiome: The investigator will investigate the alteration of gut-microbiome by restoration of bile flow at diagnosis, before and after Kasai procedure. In case of cholangitis after Kasai operation, signature gut-microbiome will be analyzed, which will lead to prevention of BA-patients from cholangitis via the bacteria transplantation. Analysis of elastography: In order to improve non-invasive diagnosis, The investigator will investigate the alteration of liver elasticity and hepatic blood flow before and after Kasai procedure as well as upon cholangitis and choledochal cyst. Those data will be analyzed in parallel with serum biochemical markers to be associated with pathophysiological events e.g., cholestasis, cholangitis and fibrosis.

Official Title
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Analysis of Gut Microbiome and Liver Imaging Including Elasticity in Biliary Atresia Patients With Cholangitis for the Prediction of Disease Activity and Improvement of Outcome Using Fecal Microbiota Transplantation

Conditions
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Biliary Atresia

Intervention / Treatment
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* Other: Monitoring of the gut-microbiome and ultrasound elasticity.
* Other: Monitoring of the gut-microbiome
* Other: Monitoring of the gut-microbiome
* Other: Monitoring of the gut-microbiome.


Participation Criteria
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Eligibility Criteria
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Biliary atresia (Disease) Inclusion Criteria: 0-4 months old Patients, diagnosed with the BA and scheduled for Kasai operation during our study period Patients whose parents or guardian understand our research aims, and comply to participate in our researches Exclusion Criteria: Patients, whose diagnosis of BA was not definite. Patients, scheduled for Kasai operation after 4 months old Choledochal cyst (Disease control) Inclusion Criteria: 0-7 years old Patients, diagnosed with choledochal cyst and scheduled for total cyst removal during our study period Patients whose parents or guardian understand our research aims, and comply to participate in our researches Exclusion Criteria: Patients, whose diagnosis of choledochal cysts was not definite. Patients with choledochal cyst, but greater than 7 years old Neonatal hepatitis (Disease control) Inclusion Criteria: 0-4 months old Patients, diagnosed with the neonatal hepatitis during our study period Patients whose parents or guardian understand our research aims, and comply to participate in our researches Exclusion Criteria: Patients with hepatobiliary infection Patients, required to use antibiotics to treat the infection Patients with hepatobiliary inflammation, caused by abnormal intra- or extra-hepatic structure Healthy control Inclusion Criteria: 0-4 months old Healthy neonates without chronic diseases when they visit for vaccination Healthy neonates whose parents or guardian understand our research aims, and comply to participate in our researches Exclusion Criteria: Patients with hepatobiliary infection Patients, required to use antibiotics to treat the infection Neonates with less than 37 weeks (i.e., preterm) or hospitalized in neonatal intensive care unit Patients, diagnosed with congenital malformation, syndrome and chronic diseases

Ages Eligible for Study
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Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Biliary Atresia<br>Disease group | Other: Monitoring of the gut-microbiome and ultrasound elasticity.<br>* The investigator will investigate the alteration of gut-microbiome and liver stiffness by restoration of bile flow by operation.<br>|
| Choledochal cyst<br>Disease control | Other: Monitoring of the gut-microbiome<br>* The investigator will investigate the alteration of gut-microbiome before and after operation.<br>|
| Neonatal hepatitis<br>Disease control | Other: Monitoring of the gut-microbiome<br>* The investigator will investigate the alteration of gut-microbiome along with the disease progress.<br>|
| Healthy baby<br>Healthy control | Other: Monitoring of the gut-microbiome.<br>* The investigator will investigate the alteration of gut-microbiome according to the normal development.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes of gut-microbiome according to the disease. | Using shotgun metagenomic analysis, we will analyze the alteration of gut-microbiota according to the disease phenotypes. | 1year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of gut microbiome according to the clinical outcomes of biliary atresia. | The investigator will compare gut-microbiome according to the disease prognosis measured by ultrasound elastography and laboratory tests. | 1year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biliary atresia, Microbiota, Cholangitis