Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-30 @ 4:05 AM
Study NCT ID:
NCT04260503
Status:
UNKNOWN
Last Update Posted:
2020-02-17
First Post:
2020-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gut Microbiome in Biliary Atresia
Sponsor:
Yonsei University
Organization:
Study Overview
Official Title:
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
Status:
UNKNOWN
Status Verified Date:
2020-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: