UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036526 |
|---|---|
| Receipt number | 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 | 2022/04/18 13:12:52 |
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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
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
yamasiro@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041230
