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Gut Microbiome in Biliary Atresia | Clinical Trials | Clareo Health

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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

NCT04260503•Yonsei University

View on ClinicalTrials.gov

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.

Eligibility

Age

0 - 7 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Biliary atresia (Disease)
•* 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
•* 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
•* 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
+3 more criteria

Exclusion Criteria

•* Patients, whose diagnosis of BA was not definite.
•* Patients, scheduled for Kasai operation after 4 months old
•2. Choledochal cyst (Disease control)
•* Patients, whose diagnosis of choledochal cysts was not definite.
•* Patients with choledochal cyst, but greater than 7 years old
•3. Neonatal hepatitis (Disease control)
•* 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
•4. Healthy control
+4 more criteria

Locations (1)

Pediatric Gastroenterology, Hepatology and Nutrition, Yonsei University College of Medicine

Seoul, South Korea

Key Dates

Start Date

May 21, 2019

Primary Completion Date

May 20, 2022

Completion Date

May 20, 2022

Last Updated

February 17, 2020

Enrollment

ESTIMATED participants

Conditions

Biliary Atresia

Interventions

Monitoring of the gut-microbiome and ultrasound elasticity.

OTHER

Monitoring of the gut-microbiome

OTHER

Monitoring of the gut-microbiome

OTHER

Monitoring of the gut-microbiome.

OTHER

Contacts

Hong Koh, Ph.D

CONTACT

82-2-2228-2050 khong@yuhs.ac

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RECRUITING

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RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Gut Microbiome in Biliary Atresia

Inclusion Criteria

Exclusion Criteria

Biliary Atresia Study in Infants and Children

High Medium-chain Triglyceride Nutritional Support in Infants With Biliary Atresia

Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin

Pentoxifylline Therapy in Biliary Atresia

Early Predictors for the Short Term Native Liver Survival in Patients With Biliary Atresia After Kasai Procedure

Predictive Models of Hepatic Decompensation and Survival Outcomes in Pediatric Patients With Cirrhosis