UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015494 |
|---|---|
| Receipt number | R000017649 |
| Scientific Title | Effects of maternal lifestyle and breast milk composition on development of the infants. (The Japanese breast milk study) |
| Date of disclosure of the study information | 2014/10/25 |
| Last modified on | 2024/10/30 19:21:36 |
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Basic information
Public title
Effects of maternal lifestyle and breast milk composition on development of the infants. (The Japanese breast milk study)
Acronym
Effects of maternal lifestyle and breast milk composition on development of the infants.
Scientific Title
Effects of maternal lifestyle and breast milk composition on development of the infants. (The Japanese breast milk study)
Scientific Title:Acronym
Effects of maternal lifestyle and breast milk composition on development of the infants.
Region
| Japan |
Condition
Condition
Healthy lactating women and their infants
Classification by specialty
| Obstetrics and Gynecology | Pediatrics | Adult |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the interaction among maternal lifestyle, breast milk composition, development of the infants.
Basic objectives2
Others
Basic objectives -Others
Prospective observational study.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Relationship between maternal lifestyle factors and breast milk composition.
2. Relationship between breast milk composition and development of the infants.
3. Relationship between maternal lifestyle factors and development of the infants.
4. Interaction among maternal lifestyle factors, breast milk composition and development of the infants.
Key secondary outcomes
1. Composition of breast milk
1) Macronutrient
2) Micronutrient
2. Maternal life style factors
1) Lifestyle behavior
2) Nutrient and food intake
3) Backgrounds (Age, Weight, Length)
3. Developmental factors of infant
1) Growth (Weight, Length)
2) Development scale
3) History of disease and allergy
4) Food intake
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 infants who are less than 60 days old.
2. Healthy lactating women who delivered infants and are not disturbed the breastfeeding even though they provide breast milk for this study.
Key exclusion criteria
1. The subjects who were positive hepatitis B or hepatitis C or HIV infections by health examinations.
2. The subjects who are undergoing medical treatment.
3. The subjects who are judged to be unsuitable by the responsible doctor of this study.
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | Toshiaki |
| Middle name | |
| Last name | Ishii |
Organization
Bean Stalk Snow Co., Ltd
Division name
Research & Development Dept.
Zip code
3501165
Address
1-2, minamidai, 1-chome, kawagoe, saitama
TEL
049-242-8138
t-ishii@beanstalksnow.co.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Higurashi |
Organization
Bean Stalk Snow Co., Ltd
Division name
Research & Development Dept.
Zip code
3501165
Address
1-2, minamidai, 1-chome, kawagoe, saitama
TEL
049-242-8138
Homepage URL
s-higurashi@beanstalksnow.co.jp
Sponsor or person
Institute
Bean Stalk Snow Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Bean Stalk Snow 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
Fukuda Clinic internal review board
Address
Shin-Osaka Brick Building 2F, 1-6-1, Miyahara, Yodogawa-ku, Osaka, Osaka
Tel
06-6398-0203
sugino@soiken.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
| 2014 | Year | 10 | Month | 25 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/1660-4601/17/6/1869/htm
Publication of results
Partially published
Result
URL related to results and publications
https://bmjopen.bmj.com/content/11/12/e055028
Number of participants that the trial has enrolled
1122
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
| 2014 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2014 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study.
We assess the interactions among maternal lifestyle, breast milk composition, growth and development of the infants.
Sample and data collection
1. Breast milk samples and Maternal data are collected during 0-12 month of postpartum.
2. Infant data are collected during 0-12 month old and follow-up until 5 years.
Management information
Registered date
| 2014 | Year | 10 | Month | 21 | Day |
Last modified on
| 2024 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017649
