UMIN-CTR Clinical Trial

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	No longer recruiting
Date of protocol fixation	2019 Year 04 Month 03 Day
Date of IRB	2019 Year 04 Month 03 Day
Anticipated trial start date	2019 Year 05 Month 21 Day
Last follow-up date	2022 Year 12 Month 31 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	2022 Year 04 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041230