Study Results
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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UNKNOWN
36 participants
OBSERVATIONAL
2019-05-21
2022-05-20
Brief Summary
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1. 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.
2. 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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Biliary Atresia
Disease group
Monitoring of the gut-microbiome and ultrasound elasticity.
The investigator will investigate the alteration of gut-microbiome and liver stiffness by restoration of bile flow by operation.
Choledochal cyst
Disease control
Monitoring of the gut-microbiome
The investigator will investigate the alteration of gut-microbiome before and after operation.
Neonatal hepatitis
Disease control
Monitoring of the gut-microbiome
The investigator will investigate the alteration of gut-microbiome along with the disease progress.
Healthy baby
Healthy control
Monitoring of the gut-microbiome.
The investigator will investigate the alteration of gut-microbiome according to the normal development.
Interventions
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Monitoring of the gut-microbiome and ultrasound elasticity.
The investigator will investigate the alteration of gut-microbiome and liver stiffness by restoration of bile flow by operation.
Monitoring of the gut-microbiome
The investigator will investigate the alteration of gut-microbiome before and after operation.
Monitoring of the gut-microbiome
The investigator will investigate the alteration of gut-microbiome along with the disease progress.
Monitoring of the gut-microbiome.
The investigator will investigate the alteration of gut-microbiome according to the normal development.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
* 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, scheduled for Kasai operation after 4 months old
2. Choledochal cyst (Disease control)
* Patients, whose diagnosis of choledochal cysts was not definite.
* Patients with choledochal cyst, but greater than 7 years old
3. Neonatal hepatitis (Disease control)
* 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
4. Healthy control
* 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
7 Years
ALL
Yes
Sponsors
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Yonsei University
OTHER
Responsible Party
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Locations
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Pediatric Gastroenterology, Hepatology and Nutrition, Yonsei University College of Medicine
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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4-2019-0306
Identifier Type: -
Identifier Source: org_study_id
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