UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042508 |
|---|---|
| Receipt number | 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 | 2023/11/24 20:50:40 |
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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
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/
myowa.masako.4x@kyoto-u.ac.jp
Sponsor or person
Institute
Developmental Science Laboratory, Graduate School of Education, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
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
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
2673
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Papers are currently in the submission process (although part of the study results have been published in an academic journal: https://www.mdpi.com/2076-2607/11/9/2245)
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
| 2020 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 13 | Day |
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
| 2023 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048490
| 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 |
