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 |
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
Probiotics supplementation for improvement of intestinal bacteria in infants born by C-section
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
Probiotics for C-section born infants
Japan |
Infants born by C-section
Pediatrics |
Others
NO
To confirm that improvement of dysbiosis and benefits to growth of the subjects with daily supplement of bifidobacteria in the early infant days
Safety,Efficacy
Improvement of dysbiosis, including early colonization and its persistence of bifidobacteria
1. Infant growth and development, 2. Intestinal microbiota, 3. Intestinal environment
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
Daily supplement of bifidobacterial from the 1st day of life for one month
Daily supplement of placebo from the 1st day of life for one month
1 | days-old | <= |
1 | days-old | >= |
Male and Female
Apparently healthy newborns by C-section
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
50
1st name | Yuichiro |
Middle name | |
Last name | Yamashiro |
Juntendo University Graduate School of Medicine
Probiotics Research Laboratory
113-8421
2-1-1 Hongo, Bunkyo-ku, Tokyo
03-5689-0082
yamasiro@juntendo.ac.jp
1st name | Yuichiro |
Middle name | |
Last name | Yamashiro |
Juntendo University Graduate School of Medicine
Probiotics Research Laboratory
113-8421
2-1-1 Hongo, Bunkyo-ku, Tokyo
03-5689-0082
yamasiro@juntendo.ac.jp
Juntendo University
Juntendo University
Self funding
Japan
Yakult Central Institute
Juntendo Hospital Ethics Committee
3-1-3 Hongo, Bukyo-ku, Tokyo
03-5802-1584
kenkyu5858@juntendo.ac.jp
NO
順天堂大学医学部附属順天堂医院(東京都)
2019 | Year | 04 | Month | 16 | Day |
Unpublished
No longer recruiting
2019 | Year | 04 | Month | 03 | Day |
2019 | Year | 04 | Month | 03 | Day |
2019 | Year | 05 | Month | 21 | Day |
2022 | Year | 12 | Month | 31 | Day |
2019 | Year | 04 | Month | 16 | Day |
2022 | Year | 04 | Month | 18 | Day |
Value
https://center6.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 |