- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04260503
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
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Hong Koh, Ph.D
- Phone Number: 82-2-2228-2050
- Email: khong@yuhs.ac
Study Locations
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-
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Seoul, Korea, Republic of
- Recruiting
- Pediatric Gastroenterology, Hepatology and Nutrition, Yonsei University College of Medicine
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Contact:
- Hong Koh, Ph.D
- Email: khong@yuhs.ac
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
- Biliary atresia Patients, diagnosed with the BA and scheduled for Kasai operation at Severance children's hospital during study period
- Choledochal cyst Patients, diagnosed with choledochal cyst and scheduled for total cyst removal at Severance children's hospital during study period
- Neonatal hepatitis Patients, diagnosed with the neonatal hepatitis during study period at Severance chilren's hospital
- Healthy control Healthy neonates without chronic diseases when they visit Severance chilren's hospital for vaccination
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Biliary Atresia
Disease group
|
The investigator will investigate the alteration of gut-microbiome and liver stiffness by restoration of bile flow by operation.
|
Choledochal cyst
Disease control
|
The investigator will investigate the alteration of gut-microbiome before and after operation.
The investigator will investigate the alteration of gut-microbiome along with the disease progress.
|
Neonatal hepatitis
Disease control
|
The investigator will investigate the alteration of gut-microbiome before and after operation.
The investigator will investigate the alteration of gut-microbiome along with the disease progress.
|
Healthy baby
Healthy control
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The investigator will investigate the alteration of gut-microbiome according to the normal development.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The changes of gut-microbiome according to the disease.
Time Frame: 1year
|
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.
Time Frame: 1year
|
The investigator will compare gut-microbiome according to the disease prognosis measured by ultrasound elastography and laboratory tests.
|
1year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4-2019-0306
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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