UMIN-CTR Clinical Trial

Basic information
Public title	Chiba Study of Mother and Child Health
Acronym	C-MACH
Scientific Title	Chiba Study of Mother and Child Health
Scientific Title:Acronym	C-MACH
Region	Japan

Condition
Condition	None
Classification by specialty	Adult Child
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To explore the effects of genetic and environmental factors on children's health
Basic objectives2	Others
Basic objectives -Others	Allergic diseases Noncommunicable diseases Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Onset of allergic diseases Obesity Others
Key secondary outcomes

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	Pregnant women planning to deliver
Key exclusion criteria	1)Those who are planning to deliver other than the cooperating medical institutions 2) Those who plan to register with the cord blood bank
Target sample size	3000

Research contact person
Name of lead principal investigator	1st name Chisato Middle name Last name Mori
Organization	Chiba University
Division name	Department of Bioenvironmental Medicine, Graduate School of Medicine
Zip code	260-0856
Address	1-8-1 Inohana, Chuo-ku, Chiba
TEL	043-226-2015
Email	cmori@faculty.chiba-u.jp

Public contact
Name of contact person	1st name Midori Middle name Last name Yamamoto
Organization	Chiba University
Division name	Center for Preventive Medical Sciences
Zip code	263-8522
Address	1-33 Yayoi-cho, Inage-ku, Chiba
TEL	043-290-3896
Homepage URL
Email	midoriy@faculty.chiba-u.jp

Sponsor
Institute	Center for Preventive Medical Sciences, Chiba University
Institute
Department

Funding Source
Organization	the Ministry of Education, Culture, Sports, Science and Technology Japan Science and Technology Agency
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Research Organization for Nano & Life Innovation, Waseda University Department of Neurobiology & Behavior, Nagasaki University Graduate School of Biomedical Sciences Department of System Cybernetics, Graduate School of Engineering, Hiroshima University Innate Immunity Laboratory, Department of Cell Biological Science, Graduate School of Life Science, Hokkaido University RIKEN Center for Integrative Medical Sciences Human Genetics Laboratory, National Institute of Genetics The National Institute of Advanced Industrial Science and Technology Clinical Research Center for Allergy and Rheumatology, Sagamihara National Hospital Massachusetts General Hospital Center for Cancer Research and Harvard Medical School Sysmex Co. Graduate School of Integrated Human and Social Welfare Studies, Shukutoku University Division of Environmental Health and Occupational Medicine, National Taiwan University Probiotics Research Laboratory, Juntendo University Graduate School of Medicine Faculty of Nutrition, Kagawa Nutrition University Department of Health and Nutrition, Sendai Shirayuri Women's College Department of Food Management, School of Food, Agricultural and Environmental Sciences, Miyagi University Laboratory of Public Health, Faculty of Pharmacy, Niigata University of Pharmacy and Applied Life Sciences BiCCA (Birth Cohort Consortium of Asia) Graduate School of Frontier Sciences, The University of Tokyo Department of Molecular and Cellular Medicine, Institute of Medical Science, Tokyo Medical University Faculty of Education, Art and Science, Yamagata University Duskin Co., Ltd. Sekisui House, Ltd. Fujitsu General, Ltd. International University of Health and Welfare Teikyo University of Science Research Center for Child Mental Development, University of Fukui
Name of secondary funder(s)	Yamada Bee Company, Inc. Sekisui House, Ltd. Fujitsu General, Ltd. Duskin Co., Ltd.

IRB Contact (For public release)
Organization	Biomedical research ethics committee of the graduate school of medicine, Chiba university
Address	1-8-1 Inohana, Chuo-ku, Chiba
Tel	043-226-2462
Email	inohana-seimei@chiba-u.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	山口病院 小野寺産婦人科 みやけウィメンズクリニック 千葉市立海浜病院 愛和病院

Other administrative information
Date of disclosure of the study information	2021 Year 11 Month 29 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
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	Open public recruiting
Date of protocol fixation	2013 Year 11 Month 26 Day
Date of IRB	2013 Year 12 Month 04 Day
Anticipated trial start date	2014 Year 02 Month 13 Day
Last follow-up date	2040 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Factors: lifestyle, eating habits, others

Management information
Registered date	2021 Year 11 Month 29 Day
Last modified on	2021 Year 11 Month 29 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052749

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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