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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 36 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 7 Years
• Healthy volunteers: Accepted

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.

Conditions

• Biliary Atresia

Interventions

Type	Name	Description
OTHER	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.
OTHER	Monitoring of the gut-microbiome	The investigator will investigate the alteration of gut-microbiome before and after operation.
OTHER	Monitoring of the gut-microbiome	The investigator will investigate the alteration of gut-microbiome along with the disease progress.
OTHER	Monitoring of the gut-microbiome.	The investigator will investigate the alteration of gut-microbiome according to the normal development.

Timeline

• Start date: 2019-05-21
• Primary completion: 2022-05-20
• Completion: 2022-05-20
• First posted: 2020-02-07
• Last updated: 2020-02-17

Locations

1 site across 1 country: South Korea