UMIN-CTR Clinical Trial

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

None

Classification by specialty

Adult

Child

Classification by malignancy

Others

Genomic information

YES

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

Primary outcomes

Onset of allergic diseases
Obesity
Others

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Center for Preventive Medical Sciences, Chiba University

Institute

Department

Personal name

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

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
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)
JBiCC (The Japan Birth Cohort Consortium)
Graduate School of Frontier Sciences, The University of Tokyo
Project Division of Genomic Medicine and Disease Prevention, The Institute of Medical Science, 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
Research Center for Child Mental Development, University of Fukui
Ezaki Glico Co., Ltd.
Center for Genome-Wide Association Study, Tohoku Medical Megabank Organization
Nagaoka University of Technology
Groupe Hospitalier Pitie-Salpetriere et Sorbonne Universite

Name of secondary funder(s)

Yamada Bee Company, Inc.

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Date of disclosure of the study information

2021

Year

11

Month

29

Day

URL releasing protocol

Publication of results

Partially published

URL related to results and publications

Number of participants that the trial has enrolled

559

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

Recruitment status

No longer 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 related information

Factors: lifestyle, eating habits, others

Registered date

2021

Year

11

Month

29

Day

Last modified on

2023

Year

12

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052749