UMIN-CTR Clinical Trial

Basic information
Public title	Developmental relationships between the gut microbiome and biopsychological characteristics in human children and their mothers: A longitudinal study
Acronym	Developmental relationships between the gut microbiome and biopsychological characteristics in human children and their mothers: A longitudinal study
Scientific Title	Developmental relationships between the gut microbiome and biopsychological characteristics in human children and their mothers: A longitudinal study
Scientific Title:Acronym	Developmental relationships between the gut microbiome and biopsychological characteristics in human children and their mothers: A longitudinal study
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 children 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 children and their mothers.
Basic objectives2	Others
Basic objectives -Others	Explore the relationship between intestinal microbial patterns and autonomic nervous activity in children and their mothers in Japan.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	The relationships among intestinal microbial patterns, autonomic nervous activity, and cognitive development in Japanese children and mothers.
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 habit, 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
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Interventions/Control_9
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Eligibility
Age-lower limit	2 months-old <=
Age-upper limit	6 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy mothers and their children who resister for the Kyoto University Baby Research Community.
Key exclusion criteria	Mothers who attend the hospital for mental or physical diseases and children at risk for severe developmental disorders such as chromosome abnormality. Mothers who cannot understand the research contents or answer questionnaires in Japanese. Pregnant mothers.
Target sample size	200

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

Other related organizations
Co-sponsor	(1) Cykinso, Inc. (2) 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	研究対象者自宅 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） 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	2021 Year 04 Month 27 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	Terminated
Date of protocol fixation	2020 Year 10 Month 28 Day
Date of IRB	2021 Year 04 Month 27 Day
Anticipated trial start date	2021 Year 05 Month 07 Day
Last follow-up date	2031 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 -londitudinal study <method for recruiting participants> We will recruit participants through the Kyoto Baby Research Community in Japan. This study targets mother and their children from 2.5 to 3 years old who read the explanatory leaflet about this study and provide mothers' voluntary written consent for participation in this study. <measurement item> 1.feces sampling (Once per each caregiver and children) 2.autonomic nervous activity by recording heart rate. 3.physical assessment (e.g., muscle mass) 4.behavioral task (e.g., eye tracking) 5.questionnaires -Items about socioeconomic status -Items about both mothers and their children -Items about infant development -Items about mothers

Management information
Registered date	2021 Year 04 Month 27 Day
Last modified on	2022 Year 04 Month 19 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050304