UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052682 |
|---|---|
| Receipt number | R000059986 |
| Scientific Title | Association between Parent-Child Gut Microbiota and Dietary Habits with the Development of Psychological and Cognitive Functions in Children |
| Date of disclosure of the study information | 2023/11/02 |
| Last modified on | 2025/04/17 09:37:18 |
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Basic information
Public title
Association between Parent-Child Gut Microbiota and Dietary Habits with the Development of Psychological and Cognitive Functions in Children
Acronym
Association between Parent-Child Gut Microbiota with the Development of Functions in Children
Scientific Title
Association between Parent-Child Gut Microbiota and Dietary Habits with the Development of Psychological and Cognitive Functions in Children
Scientific Title:Acronym
Association between Parent-Child Gut Microbiota and Dietary Habits with the Development of Psychological and Cognitive Functions in Children
Region
| Japan |
Condition
Condition
Healthy child and adult
Classification by specialty
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to explore following points. (1) Expanding the database about gut microbiome of children and their mothers owned by our research team. (2) Examine the relationship between gut microbiome and dietary habits, as well as physical physiology, cognition, and behavioral characteristics. (3) Design services that support the improvement of physical and mental health for children and their parents.
Basic objectives2
Others
Basic objectives -Others
Explore the relationship between the gut microbiome and autonomic nervous system of infants/toddlers and their caregivers in Japan
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The relationship between the gut microbiome patterns and autonomic nervous system, and cognitive development of infants/toddlers and their caregivers.
Key secondary outcomes
Lifestyle habits (eating habits, sleep rhythm, exercise habits)
Physical characteristics (allergies, ease of catching colds)
Psychological characteristics of caregivers (childcare stress, depressive tendencies)
Children's cognitive and behavioral characteristics (temperament trends, cognitive development)
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
Children (2 months to 6 years old) attending kindergartens (nursery schools, kindergartens, or preschools) and their primary caregivers (mothers or fathers living together)
Key exclusion criteria
Caregivers who are receiving outpatient treatment for mental or physical illnesses
Children at risk of severe developmental disorders such as chromosomal abnormalities
Parents who are unable to understand the research content or answer the questionnaire in Japanese
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Aya |
| Middle name | K. |
| Last name | Takeda |
Organization
Cykinso, Inc.
Division name
Medical & Clinical Division
Zip code
151-0053
Address
Odaka Building 2F, 1-36-1 Yoyogi, Shibuya-ku, Tokyo
TEL
03-5309-2522
takeda@cykinso.co.jp
Public contact
Name of contact person
| 1st name | Aya |
| Middle name | K. |
| Last name | Takeda |
Organization
Cykinso, Inc.
Division name
Medical & Clinical Division
Zip code
151-0053
Address
Odaka Building 2F, 1-36-1 Yoyogi, Shibuya-ku, Tokyo
TEL
050-3196-9123
Homepage URL
supportdesk@cykinso.co.jp
Sponsor or person
Institute
Cykinso, Inc.
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Developmental Science Laboratory, Graduate School of Education, Kyoto University
Department of Advanced Hybrid Medicine, Graduate School of Medicine, Osaka University
Department of Food and Nutrition, Kyoto Women's University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho 6F, 1-9-10 Hamamatsucho, Minato-ku, Tokyo
Tel
050-3390-9275
jimukyoku@mail.souken-r.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 | 11 | Month | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 10 | Month | 02 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2029 | 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)
cohort study
observational study
We recruit and register research subjects once a year in kindergartens that have received consent for research cooperation from the Meiwa Laboratory of the Graduate School of Education, Kyoto University. Recruitment and registration procedures will be carried out in the same manner from the second year onwards.
However, participants for multiple years will be managed using the same ID.
Management information
Registered date
| 2023 | Year | 11 | Month | 02 | Day |
Last modified on
| 2025 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059986
