Gut Microbiome in Biliary Atresia
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
1 other identifier
observational
36
1 country
1
Brief Summary
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.
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 21, 2019
CompletedFirst Submitted
Initial submission to the registry
February 5, 2020
CompletedFirst Posted
Study publicly available on registry
February 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2022
CompletedFebruary 17, 2020
February 1, 2020
3 years
February 5, 2020
February 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Comparison of gut microbiome according to the clinical outcomes of biliary atresia.
1year
Study Arms (4)
Biliary Atresia
Disease group
Choledochal cyst
Disease control
Neonatal hepatitis
Disease control
Healthy baby
Healthy control
Interventions
The investigator will investigate the alteration of gut-microbiome and liver stiffness by restoration of bile flow by operation.
The investigator will investigate the alteration of gut-microbiome according to the normal development.
Eligibility Criteria
1. Biliary atresia Patients, diagnosed with the BA and scheduled for Kasai operation at Severance children's hospital during study period 2. Choledochal cyst Patients, diagnosed with choledochal cyst and scheduled for total cyst removal at Severance children's hospital during study period 3. Neonatal hepatitis Patients, diagnosed with the neonatal hepatitis during study period at Severance chilren's hospital 4. Healthy control Healthy neonates without chronic diseases when they visit Severance chilren's hospital for vaccination
You may qualify if:
- 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
You may not qualify if:
- Patients, whose diagnosis of BA was not definite.
- Patients, scheduled for Kasai operation after 4 months old
- Choledochal cyst (Disease control)
- 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
- Patients, whose diagnosis of choledochal cysts was not definite.
- Patients with choledochal cyst, but greater than 7 years old
- Neonatal hepatitis (Disease control)
- 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
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pediatric Gastroenterology, Hepatology and Nutrition, Yonsei University College of Medicine
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2020
First Posted
February 7, 2020
Study Start
May 21, 2019
Primary Completion
May 20, 2022
Study Completion
May 20, 2022
Last Updated
February 17, 2020
Record last verified: 2020-02