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

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Hong Koh, Ph.D
  • Phone Number: 82-2-2228-2050
  • Email: khong@yuhs.ac

Study Locations

  • Korea, Republic of
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Biliary Atresia
Disease group
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.
Choledochal cyst
Disease control
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.
Neonatal hepatitis
Disease control
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.
Healthy baby
Healthy control
Other: Monitoring of the gut-microbiome.
The investigator will investigate the alteration of gut-microbiome according to the normal development.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yonsei University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 21, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 20, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 20, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 7, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 4-2019-0306

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.

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