Gut Microbiome in Biliary Atresia

February 12, 2020 updated by: Yonsei University

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

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.

Study Overview

Study Type

Observational

Enrollment (Anticipated)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Hong Koh, Ph.D
  • Phone Number: 82-2-2228-2050
  • Email: khong@yuhs.ac

Study Locations

      • Seoul, Korea, Republic of
        • Recruiting
        • Pediatric Gastroenterology, Hepatology and Nutrition, Yonsei University College of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 7 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  1. Biliary atresia Patients, diagnosed with the BA and scheduled for Kasai operation at Severance children's hospital during study period
  2. Choledochal cyst Patients, diagnosed with choledochal cyst and scheduled for total cyst removal at Severance children's hospital during study period
  3. Neonatal hepatitis Patients, diagnosed with the neonatal hepatitis during study period at Severance chilren's hospital
  4. Healthy control Healthy neonates without chronic diseases when they visit Severance chilren's hospital for vaccination

Description

  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

    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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Biliary Atresia
Disease group
The investigator will investigate the alteration of gut-microbiome and liver stiffness by restoration of bile flow by operation.
Choledochal cyst
Disease control
The investigator will investigate the alteration of gut-microbiome before and after operation.
The investigator will investigate the alteration of gut-microbiome along with the disease progress.
Neonatal hepatitis
Disease control
The investigator will investigate the alteration of gut-microbiome before and after operation.
The investigator will investigate the alteration of gut-microbiome along with the disease progress.
Healthy baby
Healthy control
The investigator will investigate the alteration of gut-microbiome according to the normal development.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The changes of gut-microbiome according to the disease.
Time Frame: 1year
Using shotgun metagenomic analysis, we will analyze the alteration of gut-microbiota according to the disease phenotypes.
1year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2019

Primary Completion (Anticipated)

May 20, 2022

Study Completion (Anticipated)

May 20, 2022

Study Registration Dates

First Submitted

February 5, 2020

First Submitted That Met QC Criteria

February 5, 2020

First Posted (Actual)

February 7, 2020

Study Record Updates

Last Update Posted (Actual)

February 17, 2020

Last Update Submitted That Met QC Criteria

February 12, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Biliary Atresia

Clinical Trials on Monitoring of the gut-microbiome and ultrasound elasticity.

3
Subscribe