UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058765 |
|---|---|
| Receipt number | R000067193 |
| Scientific Title | Study of the relationships between breast milk composition, maternal health, child development and health, and maternal genetic diversity |
| Date of disclosure of the study information | 2025/08/20 |
| Last modified on | 2025/08/12 11:04:18 |
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Basic information
Public title
Study of the relationships between breast milk composition, maternal and child health, and maternal genetic diversity
Acronym
Substudy on Genetic Diversity within the MiNDS Study
Scientific Title
Study of the relationships between breast milk composition, maternal health, child development and health, and maternal genetic diversity
Scientific Title:Acronym
Substudy on Genetic Diversity within the MiNDS Study
Region
| Japan |
Condition
Condition
Healthy mothers and their children
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
We will conduct genetic analysis using maternal saliva samples to explore genetic variants associated with breast milk composition, maternal health status, and the growth, development, health, and gut microbiota of the child.
Basic objectives2
Others
Basic objectives -Others
By taking the identified genetic factors into account, we aim to more precisely evaluate the relationships between maternal nutritional intake and breast milk composition, as well as the child7s growth, development, and gut microbiota.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate the association between maternal genetic diversity and breast milk composition.
Key secondary outcomes
To evaluate the associations between maternal genetic diversity and child development and growth, as well as the gut microbiota and health status of both mother and child, and to further examine the relationships among these factors using multivariate analysis.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Healthy mothers and their children participating in the MiNDS Study (Registration ID: UMIN000050032)
2) Mothers who, as research participants and guardians of their children, have given an explanation in Japanese about the purpose and contents of this research, fully understood it, volunteered, and agreed to participate.
Key exclusion criteria
1) Mothers and their children who did not provide breast milk samples in the MiNDS Study
2) Mothers and their children who did not complete the background questionnaire in the MiNDS Study
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | Jinno |
Organization
Meiji Holdings Co., Ltd.
Division name
Welness Science Labs
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji, Tokyo, JAPAN
TEL
042-632-5846
shinji.jinno@meiji.com
Public contact
Name of contact person
| 1st name | Shinji |
| Middle name | |
| Last name | Jinno |
Organization
Meiji Holdings Co., Ltd.
Division name
Welness Science Labs
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji, Tokyo, JAPAN
TEL
042-632-5846
Homepage URL
shinji.jinno@meiji.com
Sponsor or person
Institute
Meiji Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Meiji Holdings 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
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, JAPAN
Tel
03-5408-1599
shiba_palace@s-palace-clinic.com
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
| 2025 | Year | 08 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 16 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2025 | Year | 08 | Month | 12 | Day |
Last modified on
| 2025 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067193
