UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033766 |
|---|---|
| Receipt number | 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 | 2024/08/19 10:20:33 |
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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 | Yuki |
| Middle name | |
| Last name | Okada |
Organization
Showa university shool of medicine
Division name
division of pediatrics
Zip code
142-8666
Address
1-5-8 Hatanodai Sinagawa-ku Tokyo
TEL
+81-3-3784-8000
y.okada@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Okada |
Organization
Showa university shool of medicine
Division name
division of pediatrics
Zip code
142-8666
Address
1-5-8 Hatanodai Sinagawa-ku Tokyo
TEL
+81-3-3784-8000
Homepage URL
y.okada@med.showa-u.ac.jp
Sponsor or person
Institute
Showa university
Institute
Department
Personal name
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
Faculty of Medicine Ethics Committee on Research for Humans
Address
1-5-8, Hahanodai, shinagawa-ku,Tokyo
Tel
+81-3-3784-8000
y.okada@med.showa-u.ac.jp
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
昭和大学病院（東京都）
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
As of August 2024, there are about 120 people registered,
and second visits are also progressing smoothly.
Results date posted
| 2024 | Year | 08 | Month | 19 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
The start was delayed by two full years due to the COVID-19 pandemic.
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
| 2024 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038514
