Gut Microbiome in Biliary Atresia

Biliary Atresia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04260503
• Other study ID #: 4-2019-0306
• Status: Recruiting
• Start date: May 21, 2019
• Est. completion date: May 20, 2022

Study information

• Verified date: February 2020
• Source: Yonsei University
• Contact: Hong Koh, Ph.D
• Phone: 82-2-2228-2050
• Email: khong[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: May 20, 2022
• Est. primary completion date: May 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Biliary Atresia

Intervention

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.
• Monitoring of the gut-microbiome
The investigator will investigate the alteration of gut-microbiome before and after operation.
• Monitoring of the gut-microbiome
The investigator will investigate the alteration of gut-microbiome along with the disease progress.
• Monitoring of the gut-microbiome.
The investigator will investigate the alteration of gut-microbiome according to the normal development.

Locations

Country	Name	City	State
Korea, Republic of	Pediatric Gastroenterology, Hepatology and Nutrition, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The changes of gut-microbiome according to the disease.	Using shotgun metagenomic analysis, we will analyze the alteration of gut-microbiota according to the disease phenotypes.	1year
Secondary	Comparison of gut microbiome according to the clinical outcomes of biliary atresia.	The investigator will compare gut-microbiome according to the disease prognosis measured by ultrasound elastography and laboratory tests.	1year