UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033766
Receipt No. R000038514
Scientific Title Research on children's lifestyle and living environment as a factor of allergic disease
Date of disclosure of the study information 2018/08/16
Last modified on 2019/02/14

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Research on children's lifestyle and living environment as a factor of allergic disease
Acronym Research on children's allergic disease onset factors
Scientific Title Research on children's lifestyle and living environment as a factor of allergic disease
Scientific Title:Acronym Research on children's allergic disease onset factors
Region
Japan

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

Objectives
Narrative objectives1 To identify lifestyle factors of allergic diseases by comparing lifestyle habits and allergic disease onset conditions.
Basic objectives2 Others
Basic objectives -Others For the children in Ogasawara village and Tokyo, we aim to identify the onset factors of allergic diseases by comparing lifestyle, lifestyle habits, living environment and allergic disease onset situation. We also clarify biomarkers related to prevention of onset.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relationship between allergic diseases and lifestyle and living environment.
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
1 years-old <=
Age-upper limit
18 years-old >=
Gender Male and Female
Key inclusion criteria All children in Ogasawara village from 0 to 18 years old
All elementary school children in Daini-enzan
All nursery school children in Hatanodai and Shimizudai.
Key exclusion criteria none
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Okada Yuki
Organization Showa university shool of medicine
Division name division of pediatrics
Zip code
Address 1-5-8 Hatanodai Sinagawa-ku Tokyo
TEL +81-3-3784-8000
Email y.okada@med.showa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Okada Yuki
Organization Showa university shool of medicine
Division name division of pediatrics
Zip code
Address 1-5-8 Hatanodai Sinagawa-ku Tokyo
TEL +81-3-3784-8000
Homepage URL
Email y.okada@med.showa-u.ac.jp

Sponsor
Institute Showa university
Institute
Department

Funding Source
Organization Novartis Pharma
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 16 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 Preinitiation
Date of protocol fixation
2018 Year 06 Month 22 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 03 Day
Last follow-up date
2019 Year 01 Month 31 Day
Date of closure to data entry
2019 Year 05 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information A questionnaire is conducted in the primary survey, and children suspected of allergic disease is extracted.
As a secondary survey, children are checked and examined to confirm the diagnosis.
Fecal examination and blood sampling test will be conducted.

Management information
Registered date
2018 Year 08 Month 15 Day
Last modified on
2019 Year 02 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038514

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.