UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042223 |
|---|---|
| Receipt number | R000047723 |
| 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- |
| Date of disclosure of the study information | 2020/10/23 |
| Last modified on | 2020/10/23 16:23:53 |
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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
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
tochi@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047723
