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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042508
Receipt No. R000048490
Scientific Title The large-scale study of intestinal bacterial flora, psychophysiological and cognitive and behavioral characteristics in infants and their mothers
Date of disclosure of the study information 2020/12/01
Last modified on 2020/11/20

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Basic information
Public title The large-scale study of intestinal bacterial flora, psychophysiological and cognitive and behavioral characteristics in infants and their mothers
Acronym The large-scale study of intestinal bacterial flora, psychophysiological and cognitive and behavioral characteristics in infants and their mothers
Scientific Title The large-scale study of intestinal bacterial flora, psychophysiological and cognitive and behavioral characteristics in infants and their mothers
Scientific Title:Acronym The large-scale study of intestinal bacterial flora, psychophysiological and cognitive and behavioral characteristics in infants and their mothers
Region
Japan

Condition
Condition Healthy adult and child
Classification by specialty
Adult Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to explore following four points. (1) create the database about intestinal bacterial flora of infants and their mothers in Japan. (2) identify factors that influence the intestinal microbial patterns. (3) examine the relationship between the intestinal bacterial flora, psychophysiological characteristics and cognitive and behavioral development. (4) design services that support the improvement of physical and mental health for infants and their mothers.
Basic objectives2 Others
Basic objectives -Others Explore intestinal microbial patterns in infants and their mothers in Japan.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes (1)The developmental changes of intestinal microbial patterns in Japanese infants and mothers.
(2)The Relationship between intestinal microbial patterns in infants and mothers and cognitive development in infants.
Key secondary outcomes We will examine the relationship between the following items and intestinal bacterial flora in order to identify factors that influence the variety and pattern of intestinal bacterial flora.
(1)lifestyle habit (e.g., food habits, sleep schedule, exercise habits)
(2)physical characteristics (e.g., allergy, susceptibility to cold viruses)
(3)psychological traits of mothers (e.g., stress, depressive tendency)
(4)infant behavioral characteristics (e.g., temperament)

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
2 months-old <=
Age-upper limit
6 years-old >=
Gender Male and Female
Key inclusion criteria Healthy caregivers (mothers) and their infants who attend nursery schools, daycare, or kindergartens in Japan. These institutions are in cooperation with this research group.
Those who have Japanese nationality and mainly live in Japan.
Key exclusion criteria Caregivers (mothers) who attend the hospital for mental or physical diseases and infants at risk for severe developmental disorders such as chromosome abnormality. Caregivers (mothers) who cannot understand the research contents or answer questionnaires in Japanese.
Target sample size 1500

Research contact person
Name of lead principal investigator
1st name Masako
Middle name
Last name Myowa
Organization Kyoto University
Division name Graduate School of Education
Zip code 606-8501
Address Yoshida-honmachi, Sakyo-ku, Kyoto 606-8501 Japan
TEL 075-753-3074
Email myowa.masako.4x@kyoto-u.ac.jp

Public contact
Name of contact person
1st name Masako
Middle name
Last name Myowa
Organization Kyoto University
Division name Graduate School of Education
Zip code 606-8501
Address Yoshida-honmachi, Sakyo-ku, Kyoto 606-8501 Japan
TEL 075-753-3074
Homepage URL http://myowa.educ.kyoto-u.ac.jp/
Email myowa.masako.4x@kyoto-u.ac.jp

Sponsor
Institute Developmental Science Laboratory, Graduate School of Education, Kyoto University
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor (1) Cykinso, Inc.
(2) Kewpie Corporation
(3) Department of Advanced Hybrid Medicine, Graduate School of Medicine, Osaka University
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, Japan
Tel 075-753-4680
Email ethcom@kuhp.kyoto-u.ac.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 (1)研究対象者自宅(例:京都府)
(2)研究対象者が通園する保育園、幼稚園、こども園(例:京都府)
(3)京都大学教育学研究科 明和研究室、発達教育実習室(京都府)
(4)国際科学イノベーション棟303号室明和研究室赤ちゃんラボ(京都府)

Other administrative information
Date of disclosure of the study information
2020 Year 12 Month 01 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
2020 Year 08 Month 06 Day
Date of IRB
Anticipated trial start date
2020 Year 12 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information <study design>
・observational study
・prospective study
・cross-sectional study

<method for recruiting participants>
We will recruit participants through nursery schools, daycare, or kindergartens in Japan. These institutions are in cooperation with this research group. This study targets caregivers (mothers) and their infants from 2 months to preschool (6 years old) who read the explanatory leaflet about this study and provide caregivers' voluntary written consent for participation in this study.

1.feces sampling (Once per each caregiver and infants)
2.questionnaires
・Items about socioeconomic status
・Items about food habits
・Items about infant cognitive development
・Items about the physical and mental health of caregivers (mothers)
3. Menu of school lunch and Interview about infants when spending time in preschool

Management information
Registered date
2020 Year 11 Month 20 Day
Last modified on
2020 Year 11 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048490

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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