Gut Microbiome in Biliary Atresia

• Conditions: Biliary Atresia
• Interventions: Other: Monitoring of the gut-microbiome; Other: Monitoring of the gut-microbiome.; Other: Monitoring of the gut-microbiome and ultrasound elasticity.

• Registration Number: NCT04260503
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-21
• Status Verified: 2020-02
• Study First Submitted: 2020-02-05
• Study First Submitted QC: 2020-02-05
• Study First Posted: 2020-02-07
• Last Update Submitted: 2020-02-12
• Last Update Posted: 2020-02-17
• Primary Completion: 2022-05-20
• Study Completion: 2022-05-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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

   Exclusion Criteria:

   • Patients, whose diagnosis of choledochal cysts was not definite.
   • Patients with choledochal cyst, but greater than 7 years old

3. 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

4. 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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Choledochal cyst	Monitoring of the gut-microbiome	Disease control
Neonatal hepatitis	Monitoring of the gut-microbiome	Disease control
Healthy baby	Monitoring of the gut-microbiome.	Healthy control
Biliary Atresia	Monitoring of the gut-microbiome and ultrasound elasticity.	Disease group

Primary Outcome Measures

Name	Time	Method
The changes of gut-microbiome according to the disease.	1year	Using shotgun metagenomic analysis, we will analyze the alteration of gut-microbiota according to the disease phenotypes.

Secondary Outcome Measures

Name	Time	Method
Comparison of gut microbiome according to the clinical outcomes of biliary atresia.	1year	The investigator will compare gut-microbiome according to the disease prognosis measured by ultrasound elastography and laboratory tests.

Trial Locations

Locations (1)

Pediatric Gastroenterology, Hepatology and Nutrition, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of