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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04260503
Enrollment
36
Registered
2020-02-07
Start date
2019-05-21
Completion date
2022-05-20
Last updated
2020-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Atresia

Keywords

Biliary atresia, Microbiota, Cholangitis

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.

Interventions

OTHERMonitoring 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.

OTHERMonitoring of the gut-microbiome

The investigator will investigate the alteration of gut-microbiome before and after operation.

OTHERMonitoring of the gut-microbiome.

The investigator will investigate the alteration of gut-microbiome according to the normal development.

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 7 Years
Healthy volunteers
Yes

Inclusion criteria

1. 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 2. 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

Design outcomes

Primary

MeasureTime frameDescription
The changes of gut-microbiome according to the disease.1yearUsing shotgun metagenomic analysis, we will analyze the alteration of gut-microbiota according to the disease phenotypes.

Secondary

MeasureTime frameDescription
Comparison of gut microbiome according to the clinical outcomes of biliary atresia.1yearThe investigator will compare gut-microbiome according to the disease prognosis measured by ultrasound elastography and laboratory tests.

Countries

South Korea

Contacts

Primary ContactHong Koh, Ph.D
khong@yuhs.ac82-2-2228-2050

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026