UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047699 |
|---|---|
| Receipt number | R000054302 |
| Scientific Title | Assessment of microbiome on mothers and offspring |
| Date of disclosure of the study information | 2022/05/16 |
| Last modified on | 2024/11/20 17:30:28 |
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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
| Obstetrics 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
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
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 | 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
| 2027 | 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
| 2024 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054302
