UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047617 |
|---|---|
| Receipt number | R000046910 |
| Scientific Title | nvestigation on the pregnancy and postpartum flora of mothers drinking Bifidobacterium fermented milk and the microbiome of the newborn from birth to 2 years of age |
| Date of disclosure of the study information | 2022/04/28 |
| Last modified on | 2024/11/20 17:30:55 |
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Basic information
Public title
Effect of Bifidobacterium fermented milk on mother and infant microbiome: sequential observation of gut microbiota during pregnancy and the first two years for infants
Acronym
Effect of Bifidobacterium fermented milk on mother and infant microbiota
Scientific Title
nvestigation on the pregnancy and postpartum flora of mothers drinking Bifidobacterium fermented milk and the microbiome of the newborn from birth to 2 years of age
Scientific Title:Acronym
Effect of Bifidobacterium fermented milk on mother and infant microbiota
Region
| Japan |
Condition
Condition
Healthy pregnant women and offspring
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study aim to evaluate the relation of bifidobacteria fermented milk on microbiota of mother and infants in association with gastrointestinal symptoms and allergy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gut microbiome
mother: during pregnancy and after childbirth
infants: the first two years
Key secondary outcomes
Vaginal microbiome
Gastrointestinal symptoms
Intestinal environment (pH, organic acid)
Allergies of infant
mother: during pregnancy and after childbirth
infants: the first two years
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Bifidobacterium fermented milk
one bottle per day
from 28 weeks to 9 weeks after childbirth
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Japanese pregnant women who are undergoing prenatal checkups at the Research Center for Child Health and Development and are planning to have childbirth and postpartum checkups at this center
Pregnant woman who plan vaginal delivery
Singleton pregnancy
Pregnancy Over 20 years old
Pregnant women who understand the research contents, show consent, and can keep the research contents confidential
Key exclusion criteria
Pregnant woman with fetal morphological abnormalities
Pregnant women with hypertension, diabetes, autoimmune disease, etc.)
Pregnant women who will be treated with antibiotics at birth
Pregnant women who participate the other innervation (e.g. other functional foods, drugs or cosmetics) during this study period.
Pregnant women with milk or gelatin allergies
Pregnant women who is not appropriate to participated the study (as judged by the medical doctor)
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tomo Suzuki |
| Middle name | |
| Last name | Suzuki |
Organization
National Center for Child Health and Development
Division name
Center for Maternal-Fetal, Neonatal and Reproductive Medicine
Zip code
157-8535
Address
2-10-1 Okura, Setagaya-ku, Tokyo, Japan
TEL
03-3416-0181
suzuki-tm@ncchd.go.jp
Public contact
Name of contact person
| 1st name | Tomo Suzuki |
| Middle name | |
| Last name | Suzuki |
Organization
National Center for Child Health and Development
Division name
Center for Maternal-Fetal, Neonatal and Reproductive Medicine
Zip code
157-8535
Address
2-10-1 Okura, Setagaya-ku, Tokyo, Japan
TEL
03-3416-0181
Homepage URL
suzuki-tm@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
Funding Source
Organization
Yakult Honsha Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
KSO Corporation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Child Health and Development
Address
2-10-1 Okura, Setagaya-ku, Tokyo, Japan
Tel
03-3416-0181
suzuki-tm@ncchd.go.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
| 2022 | Year | 04 | Month | 28 | 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
39
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
| 2020 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2022 | Year | 04 | Month | 28 | Day |
Last modified on
| 2024 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046910
