UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of environmental factors on allergic diseases in early childhood
Title of the study (Brief title)	Allergic diseases and environmental factors in early childhood
Region	Japan

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

Objectives
Narrative objectives1	In this study, we investigate effects of smoking and infections on exercise induced bronchoconstriction, nasal eosinophils, and blood or urine microRNAs between children with and without allergic diseases. And we perform global analyses of microRNAs and detect some microRNAs influencing on the development of allergic diseases (or allergic march).
Basic objectives2	Others
Basic objectives -Others	In Japan, atopy has been increasing, especially in children, and half of Japanese have some kind of allergic diseases. Allergic diseases are complexity developed from genetic factors, such as atopy, organic hypersensitivity and immune responses, and environmental factors, such as smoking, infections and diets. To reveal the mechanisms of development of allergic diseases is an effective strategy for prevention of allergic diseases and chronic inflammations. On the other hand, recently, microRNAs has been focused as biomarkers for allergic diseases, cancers and cardiac diseases. However, effects of microRNAs on allergic diseases are unclear.
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Longitudinal prospective study; global analyses of microRNAs influence on the development of allergic diseases (or allergic march)
Key secondary outcomes	1)Passive smoking and exercise induced bronchoconstriction 2)Passive smoking and nasal eosinophils 3)Nasal eosinophils and nasal micropathogens 4)Global analyses of blood microRNAs and childhood allergic diseases 5)Global analyses of urine microRNAs and childhood 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	4 years-old <=
Age-upper limit	7 years-old >
Gender	Male and Female
Key inclusion criteria	Parents and children aged 4 to 6 years in a general population who agreed with participating in the study.
Key exclusion criteria	Exclusion criteria: children with chronic diseases, expect allergic diseases. Follow off criteria: children who withdrawal the agreement.
Target sample size	40

Research contact person
Name of lead principal investigator	Eiichi Ishii
Organization	Ehime University Graduate School of Medicine
Division name	Department of Pediatrics
Address	454 Shitsukawa, Toon-City, Ehime
TEL	089-960-5111
Email	ishiei@m.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
TEL	+81-89-960-5111
Homepage URL	http://www.m.ehime-u.ac.jp/e/index.php?p=index
Email	shinohara.miwa.vv@ehime-u.ac.jp

Sponsor
Institute	Ehime University Hospital
Institute
Department

Funding Source
Organization	Delegated accounting foundation of department of pediatrics, Ehime University Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
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　小児科

Other administrative information
Date of disclosure of the study information	2016 Year 11 Month 08 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 06 Month 22 Day
Anticipated trial start date	2015 Year 06 Month 23 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	Unpublished
URL releasing results
Results
Other related information	Collect and analysis data of blood and lung function for clinical examinations and experiments for allergic diseases in Ehime University Hospital.

Management information
Registered date	2016 Year 02 Month 02 Day
Last modified on	2016 Year 11 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024042