Biliary AtresiaNCT04260503
Gut Microbiome in Biliary Atresia
An observational study of Biliary Atresia, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages Up to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Biliary Atresia
- What is being tested?
- Monitoring of the gut-microbiome and ultrasound elasticity., Monitoring of the gut-microbiome and Monitoring of the gut-microbiome.
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 May 2019to 20 May 2022
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 7 years
- All sexes
- Healthy volunteers accepted
- Child
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
Who may be able to join
- 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
Show all 12Show fewer
- 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
- 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
Who cannot join
- Patients, whose diagnosis of BA was not definite.
- Patients, scheduled for Kasai operation after 4 months old
- Choledochal cyst (Disease control)
- Patients, whose diagnosis of choledochal cysts was not definite.
- Patients with choledochal cyst, but greater than 7 years old
- Neonatal hepatitis (Disease control)
Show all 14Show fewer
- 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
- Healthy control
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Pediatric Gastroenterology, Hepatology and Nutrition, Yonsei University College of Medicine
Seoul
Hong Koh, Ph.D, khong@yuhs.ac
About this study
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
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.
- 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.
- 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.
- Conditions
- Biliary Atresia
- Being tested
- Monitoring of the gut-microbiome and ultrasound elasticity., Monitoring of the gut-microbiome, Monitoring of the gut-microbiome.
- Keywords
- Biliary atresia, Microbiota, Cholangitis
- Medical subject headings
- Biliary Atresia, Cholangitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring of the gut-microbiome and ultrasound elasticity.Other
The investigator will investigate the alteration of gut-microbiome and liver stiffness by restoration of bile flow by operation.
Monitoring of the gut-microbiomeOther
The investigator will investigate the alteration of gut-microbiome before and after operation.
Monitoring of the gut-microbiomeOther
The investigator will investigate the alteration of gut-microbiome along with the disease progress.
Monitoring of the gut-microbiome.Other
The investigator will investigate the alteration of gut-microbiome according to the normal development.
| Study group | Role | What they receive |
|---|---|---|
| Biliary Atresia | Disease group Receives: Other: Monitoring of the gut-microbiome and ultrasound elasticity. | |
| Choledochal cyst | Disease control Receives: Other: Monitoring of the gut-microbiome | |
| Neonatal hepatitis | Disease control Receives: Other: Monitoring of the gut-microbiome | |
| Healthy baby | Healthy control Receives: Other: Monitoring of the gut-microbiome. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1year
Secondary outcomes (1)
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.
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start21 May 2019
- Primary completion20 May 2022 (estimated)
- Study completion20 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary AtresiaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04260503
- Sponsor's protocol ID
- 4-2019-0306
- Status last verified
- Feb 2020
- First submitted
- 5 Feb 2020
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04260503
- Acronym / sponsor ID
- 4-2019-0306
- Conditions
- Biliary Atresia
- Keywords
- Biliary atresia, Microbiota, Cholangitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 21 May 2019 (actual)
- Primary completion
- 20 May 2022 (estimated)
- Study completion
- 20 May 2022 (estimated)
- First posted
- 7 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Biliary Atresia | – | Other: Monitoring of the gut-microbiome and ultrasound elasticity.Disease group |
| Choledochal cyst | – | Other: Monitoring of the gut-microbiomeDisease control |
| Neonatal hepatitis | – | Other: Monitoring of the gut-microbiomeDisease control |
| Healthy baby | – | Other: Monitoring of the gut-microbiome.Healthy control |
Who may qualify
- Ages
- Up to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (14 listed)
- Choledochal cyst (Disease control)
- Neonatal hepatitis (Disease control)
- Healthy control
- Patients with hepatobiliary infection
- Patients, required to use antibiotics to treat the infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Biliary Atresia |
| Monitoring of the gut-microbiomeThe investigator will investigate the alteration of gut-microbiome before and after operation. | Other | Choledochal cyst |
| Monitoring of the gut-microbiomeThe investigator will investigate the alteration of gut-microbiome along with the disease progress. | Other | Neonatal hepatitis |
| Monitoring of the gut-microbiome.The investigator will investigate the alteration of gut-microbiome according to the normal development. | Other | Healthy baby |
Primary outcome
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.
1 secondary outcome
Comparison of gut microbiome according to the clinical outcomes of biliary atresia.
Time frame: 1year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Atresia, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hong Koh, Ph.D (82-2-2228-2050, khong@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes of gut-microbiome according to the disease. (time frame: 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.