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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000047699
Receipt No. R000054302
Scientific Title Assessment of microbiome on mothers and offspring
Date of disclosure of the study information 2022/05/16
Last modified on 2022/05/10

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Basic information
Public title Assessment of microbiome on mothers and offspring
Acronym Assessment of microbiome on mothers and offspring
Scientific Title Assessment of microbiome on mothers and offspring
Scientific Title:Acronym Assessment of microbiome on mothers and offspring
Region
Japan

Condition
Condition Healthy pregnant women and offspring
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the microbiota of mothers and infants and the association with pregnancy outcomes, allergic symptoms and gastrointestinal symptoms.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Gut microbiome
mothers: during pregnancy and after childbirth
infants: the first two years
Key secondary outcomes vaginal microbiome
gastrointestinal symptoms
intestinal environment(pH, organic acid)
allergic of infant
mother:during pregnancy and after childbirth
infants: the first two years

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 National Center for Child Health and Development and are planning to have childbirth and postpartum checkup at this center

pregnant women who plan vaginal delivery
singleton pregnancy over 20 years old
with well-understanding and keeping the secret about this study
Key exclusion criteria the pregnant women with fetal morphological abnormalities
pregnant women with hypertension, diabetes, autoimmune diseases, etc
pregnant women who will be treated with antibiotics at childbirth
pregnant women who participate the other study related with foods, medicines and cosmetics
pregnant women who are considered not available this study participation
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
Email 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
Email suzuki-tm@ncchd.go.jp

Sponsor
Institute National Center for Child Health and Development
Institute
Department

Funding Source
Organization Yakult Honsha Co.,Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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
Email 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 05 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 40
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
2021 Year 03 Month 09 Day
Date of IRB
2021 Year 03 Month 09 Day
Anticipated trial start date
2021 Year 03 Month 26 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We are assessing about microbiota of mothers and infants

Management information
Registered date
2022 Year 05 Month 10 Day
Last modified on
2022 Year 05 Month 10 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054302

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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