UMIN-CTR Clinical Trial

Basic information
Public title	Clinical research of the health management support for long-term biliary atresia survivors -assessment of nutrition, microbiota, bile acid, metabolism and immune system associated with liver dysfunction and various drugs-
Acronym	Clinical research of the health management support for long-term biliary atresia survivors -assessment of nutrition, microbiota, bile acid, metabolism and immune system associated with liver dysfunction and various drugs-
Scientific Title	Clinical research of the health management support for long-term biliary atresia survivors -assessment of nutrition, microbiota, bile acid, metabolism and immune system associated with liver dysfunction and various drugs-
Scientific Title:Acronym	Clinical research of the health management support for long-term biliary atresia survivors -assessment of nutrition, microbiota, bile acid, metabolism and immune system associated with liver dysfunction and various drugs-
Region	Japan

Condition
Condition	Biliary atresia
Classification by specialty	Hepato-biliary-pancreatic medicine Surgery in general Hepato-biliary-pancreatic surgery Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To reveal the health problems of the long-term biliary atresia survivors by measuring bile acid, fatty acid, and microbiota.
Basic objectives2	Others
Basic objectives -Others	Contribute the healthy management support to the long-term biliary atresia survivors.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood test (complete blood count, serum chemistry, bile acid, fatty acid) and stool analysis (microbiota, organic acid) are performed.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Maneuver
Interventions/Control_1	A blood sample is taken.
Interventions/Control_2	A stool sample is collected.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	1 days-old <=
Age-upper limit	40 years-old >
Gender	Male and Female
Key inclusion criteria	Subjects who were diagnosed biliary atresia and treated by Kasai portoenterostomy or liver transplantation.
Key exclusion criteria	Subjects who are deemed inappropriate to participate in this study by the principle investigator.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Yuichiro Middle name Last name Yamashiro
Organization	Juntendo University School of Medicine
Division name	Probiotics Research Laboratory
Zip code	113-8421
Address	2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL	03-3813-3111
Email	yamashiro@juntendo.ac.jp

Public contact
Name of contact person	1st name Takanori Middle name Last name Ochi
Organization	Juntendo University School of Medicine
Division name	Department of Pediatric General and Urogenital Surgery
Zip code	113-8421
Address	2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL	03-3813-3111
Homepage URL
Email	tochi@juntendo.ac.jp

Sponsor
Institute	Juntendo University
Institute
Department

Funding Source
Organization	Yakult Honsha Co.,Ltd.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Juntendo University School of Medicine
Address	2-1-1 Hongo, Bunkyo-ku, Tokyo
Tel	03-3813-3111
Email	yamashiro@juntendo.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 10 Month 23 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2020 Year 09 Month 04 Day
Date of IRB	2020 Year 08 Month 24 Day
Anticipated trial start date	2020 Year 09 Month 04 Day
Last follow-up date	2022 Year 12 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 10 Month 23 Day
Last modified on	2020 Year 10 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047723