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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000046084
Receipt No. R000052608
Scientific Title Observational study of the effects of differences in hygiene practices and hands ingredients on prevention of infectious diseases
Date of disclosure of the study information 2021/11/17
Last modified on 2021/11/16

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Basic information
Public title Observational study of the effects of differences in hygiene practices and hands ingredients on prevention of infectious diseases
Acronym Effects of different hygiene practices on prevention of infectious diseases
Scientific Title Observational study of the effects of differences in hygiene practices and hands ingredients on prevention of infectious diseases
Scientific Title:Acronym Effects of different hygiene practices on prevention of infectious diseases
Region
Japan

Condition
Condition healthy human
Classification by specialty
Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Identify the relationship between hygiene practices and prevention of infectious diseases
Basic objectives2 Others
Basic objectives -Others cohort study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between hygiene practices and incidence of acute upper respiratory infection
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
6 years-old <=
Age-upper limit
11 years-old >=
Gender Male and Female
Key inclusion criteria 1st grade to 5th grade
Key exclusion criteria 1, Those who cannot obtain written parental consent for participation in this study.
2, Those who have not obtained their child's approval for participation in this study.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Mitsuo
Middle name
Last name Uchida
Organization Gunma University
Division name Graduate School of Medicine, Department of Public Health
Zip code 371-8511
Address 3-39-22, Showamachi, Maebashi-shi, Gunma, 371-8511, JAPAN
TEL +81-27-220-8014
Email uchida01@gunma-u.ac.jp

Public contact
Name of contact person
1st name Mitsuo
Middle name
Last name Uchida
Organization Gunma University
Division name Graduate School of Medicine, Department of Public Health
Zip code 371-8511
Address 3-39-22, Showamachi, Maebashi-shi, Gunma, 371-8511, JAPAN
TEL +81-27-220-8014
Homepage URL
Email uchida01@gunma-u.ac.jp

Sponsor
Institute Gunma University
Institute
Department

Funding Source
Organization Kao corporation
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 Gunma University Hospital Clinical Research Review Board
Address 3-39-22, Showamachi, Maebashi-shi, Gunma, 371-8511
Tel 027-220-8740
Email ciru_hitotaisho-irb@ml.gunma-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

Other administrative information
Date of disclosure of the study information
2021 Year 11 Month 17 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 Open public recruiting
Date of protocol fixation
2021 Year 09 Month 03 Day
Date of IRB
2021 Year 09 Month 03 Day
Anticipated trial start date
2021 Year 11 Month 11 Day
Last follow-up date
2022 Year 03 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information prospective cohort study
Method of recruitment (parents and elementary school students from one elementary school who meet the selection criteria and agree in writing)

Management information
Registered date
2021 Year 11 Month 16 Day
Last modified on
2021 Year 11 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052608

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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