UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050032 |
|---|---|
| Receipt number | R000056996 |
| Scientific Title | Study of the relationships between maternal nutritional intake, breast milk composition, child development, and intestinal microflora |
| Date of disclosure of the study information | 2023/01/17 |
| Last modified on | 2023/09/11 09:43:33 |
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Basic information
Public title
Study of the relationships between maternal nutritional intake, breast milk composition, and child development
Acronym
Maternal and Child Nutrition Study in Japan
Scientific Title
Study of the relationships between maternal nutritional intake, breast milk composition, child development, and intestinal microflora
Scientific Title:Acronym
Maternal and Child Nutrition Study in Japan
Region
| Japan |
Condition
Condition
Healthy mothers and their infants
Classification by specialty
| Obstetrics and Gynecology | Pediatrics | Adult |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By conducting a new large-scale breast milk survey, we will verify whether the nutritional composition of Japanese breast milk has changed since the previous survey (1998-1999).
Basic objectives2
Others
Basic objectives -Others
Evaluate the effects of maternal gestational age and child's birth weight on the nutritional composition of breast milk, as well as the relationships between maternal nutritional intake, breast milk composition, child development, and intestinal flora.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Verification of whether the nutritional component composition of current Japanese breast milk has changed from the values measured in the previous survey (1998-1999).
Key secondary outcomes
Evaluate the effects of maternal gestational age and child's birth weight on the nutritional composition of breast milk, as well as the relationships between maternal nutritional intake, breast milk composition, child development, and intestinal flora.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Healthy mothers aged 18 years or older immediately after giving birth to 60 days after giving birth, and their infant.
Mothers who can answer questionnaires in Japanese using a smartphone or personal computer.
Mothers who, as research participants and guardians of their infants, 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
Mothers with multiple births.
Infants diagnosed with an inborn error of metabolism.
Mothers and their infants participating in other human subjects research as of the date of consent.
Mothers who have already consented to and participated in this study in the past.
Target sample size
1100
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | Jinno |
Organization
Meiji Co., Ltd.
Division name
Food Microbiology and Function Research Laboratories, R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji, Tokyo, JAPAN
TEL
042-632-5848
shinji.jinno@meiji.com
Public contact
Name of contact person
| 1st name | Shinji |
| Middle name | |
| Last name | Jinno |
Organization
Meiji Co., Ltd.
Division name
Food Microbiology and Function Research Laboratories, R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji, Tokyo, JAPAN
TEL
042-632-5848
Homepage URL
https://www.boshieiyou-lb.com/
shinji.jinno@meiji.com
Sponsor or person
Institute
Meiji Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Meiji Holdings Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Meiji Institutional Review Board
Address
1-29-1 Nanakuni, Hachioji, Tokyo, JAPAN
Tel
042-632-5900
MEIJI.IRB@meiji.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
| 2023 | Year | 01 | Month | 17 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 12 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Uncontrolled, observational study
Management information
Registered date
| 2023 | Year | 01 | Month | 13 | Day |
Last modified on
| 2023 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056996
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
