UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Epidemiological studies about effects of environmental and genetic factors for the development of allergic diseases in general population
Title of the study (Brief title)	Effects of environmental and genetic factors for the development of allergic diseases in general population
Region	Japan

Condition
Condition	Allergic diseases
Classification by specialty	Clinical immunology Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To reveal effects of feto-maternal or infant-maternal interactions among prenatal environmental factors, such as diet, infections and earth conditions, and genetic factors on the development of allergic diseases in a general population by using epidemiological methods.
Basic objectives2	Others
Basic objectives -Others	To apply the results from the studies to strategy for prevention and treatment of allergic diseases.
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	development of allergic diseases
Key secondary outcomes	Timing of development of allergic diseases Cure or tolerance of allergic diseases

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	0 months-old <=
Age-upper limit	24 months-old >
Gender	Male and Female
Key inclusion criteria	Kochi Baby Examination has been held annually in spring since the end of the 2nd World War, and is a large baby health medical examination for around 2500 newborn babies in a general population in Kochi, Japan. The Kochi Baby Examination has been supposed by the Kochi Shinbun-Broadcasting in Kochi, Japan. Objectives: * Parents-baby pairs in a general population who participated to the Kochi Baby Examination. * Parents-baby pairs with written informed consent.
Key exclusion criteria	Parents-baby pairs without written informed consent.
Target sample size	2500

Research contact person
Name of lead principal investigator	Miwa Shinohara
Organization	Ehime University Hospital
Division name	Department of Pediatrics
Address	454 Shitsukawa, Toon-City Ehime, 791-0295, JAPAN
TEL	089-960-5320
Email	shinohara.miwa.vv@ehime-u.ac.jp

Public contact
Name of contact person	Miwa Shinohara
Organization	Ehime University Hospital
Division name	Department of Pediatrics
Address	454 Shitsukawa, Toon-City Ehime, 791-0295, JAPAN
TEL	089-960-5320
Homepage URL
Email	shinohara.miwa.vv@ehime-u.ac.jp

Sponsor
Institute	Department of Pediatrics, Ehime University Hospital
Institute
Department

Funding Source
Organization	Ehime University Hospital Department of Pediatrics
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of Allergy and Immunology, National Center for Child Health and Development
Name of secondary funｄer(s)

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	愛媛大学医学部附属病院（愛媛県）

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 13 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	1999 Year 01 Month 01 Day
Anticipated trial start date	1999 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results	Our results suggest the presence of possible epigenetic mechanisms regulating the onset of AR in humans presumably through increased organ-specific hypersensitivity.
Other related information	Allergol Int. 2007 Dec;56(4):411-7. Epub 2007 Sep 1. Symptoms of allergic rhinitis in women during early pregnancy are associated with higher prevalence of allergic rhinitis in their offspring. Shinohara M1, Wakiguchi H, Saito H, Matsumoto K. https://www.ncbi.nlm.nih.gov/pubmed/17713362

Management information
Registered date	2017 Year 04 Month 13 Day
Last modified on	2018 Year 08 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022170