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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036526
Receipt No. R000041230
Scientific Title Effects of the enternal administration of Bifidobacterium breve (BBG-01, Yakult) for dysbiosis of infants born by C-section on of their growth and development
Date of disclosure of the study information 2019/04/16
Last modified on 2019/04/16

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Basic information
Public title Effects of the enternal administration of Bifidobacterium breve (BBG-01, Yakult) for dysbiosis of infants born by C-section on of their growth and development
Acronym Probiotics supplementation for improvement of intestinal bacteria in infants born by C-section
Scientific Title Effects of the enternal administration of Bifidobacterium breve (BBG-01, Yakult) for dysbiosis of infants born by C-section on of their growth and development
Scientific Title:Acronym Probiotics for C-section born infants
Region
Japan

Condition
Condition Infants born by C-section
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm that improvement of dysbiosis and benefits to growth of the subjects with daily supplement of bifidobacteria in the early infant days
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement of dysbiosis, including early colonization and its persistence of bifidobacteria
Key secondary outcomes 1. Infant growth and development, 2. Intestinal microbiota, 3. Intestinal environment

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Daily supplement of bifidobacterial from the 1st day of life for one month
Interventions/Control_2 Daily supplement of placebo from the 1st day of life for one month
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
1 days-old >=
Gender Male and Female
Key inclusion criteria Apparently healthy newborns by C-section
Key exclusion criteria Newborn those who are judged in appropriate for the enrollment for the study by one of doctors who performed C-section, charged for the study or the final responsibility
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Yuichiro
Middle name
Last name Yamashiro
Organization Juntendo University Graduate School of Medicine
Division name Probiotics Research Laboratory
Zip code 113-8421
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-5689-0082
Email yamasiro@juntendo.ac.jp

Public contact
Name of contact person
1st name Yuichiro
Middle name
Last name Yamashiro
Organization Juntendo University Graduate School of Medicine
Division name Probiotics Research Laboratory
Zip code 113-8421
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-5689-0082
Homepage URL
Email yamasiro@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization Juntendo University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization Juntendo Hospital Ethics Committee
Address 3-1-3 Hongo, Bukyo-ku, Tokyo
Tel 03-5802-1584
Email kenkyu5858@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 順天堂大学医学部附属順天堂医院(東京都)

Other administrative information
Date of disclosure of the study information
2019 Year 04 Month 16 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 Preinitiation
Date of protocol fixation
2019 Year 04 Month 03 Day
Date of IRB
Anticipated trial start date
2019 Year 05 Month 21 Day
Last follow-up date
2020 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 04 Month 16 Day
Last modified on
2019 Year 04 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041230

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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