UMIN-CTR Clinical Trial

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	460
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	Completed
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	2022 Year 11 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052608