UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046084 |
|---|---|
| Receipt number | 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 | 2022/11/16 09:07:44 |
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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
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
uchida01@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052608
