UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020841 |
|---|---|
| Receipt number | R000024042 |
| Scientific Title | Effects of environmental factors on allergic diseases in early childhood |
| Date of disclosure of the study information | 2016/11/08 |
| Last modified on | 2016/11/08 10:33:33 |
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Basic information
Public title
Effects of environmental factors on allergic diseases in early childhood
Acronym
Allergic diseases and environmental factors in early childhood
Scientific Title
Effects of environmental factors on allergic diseases in early childhood
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Eiichi Ishii |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Pediatrics
Zip code
Address
454 Shitsukawa, Toon-City, Ehime
TEL
089-960-5111
ishiei@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miwa Shinohara |
Organization
Ehime University Hospital
Division name
Department of Pediatrics
Zip code
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
shinohara.miwa.vv@ehime-u.ac.jp
Sponsor or person
Institute
Ehime University Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 06 | Month | 22 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024042
