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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052608