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 2023/09/11 13:12:21

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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 Uchida

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

Email

t-uchida@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


Email

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

Email

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

2023 Year 09 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017649


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name