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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035541
Receipt No. R000040497
Scientific Title A study on the relevance between biological barrier and morbidity of infection.
Date of disclosure of the study information 2019/01/16
Last modified on 2019/07/17

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Basic information
Public title A study on the relevance between biological barrier and morbidity of infection.
Acronym A study on the relevance between biological barrier and morbidity of infection.
Scientific Title A study on the relevance between biological barrier and morbidity of infection.
Scientific Title:Acronym A study on the relevance between biological barrier and morbidity of infection.
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Infectious disease Dermatology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to reveal the effect of biological barrier on morbidity of infection in winter when infection are prevalent
Basic objectives2 Others
Basic objectives -Others General survey to reveal the relevance between biological barrier and morbidity of infection.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Indicators of biological barrier;
ex) activity of immune cells, body temperature, antiviral activity
Key secondary outcomes Questionnaire survey about lifestyle, rate of infection diseases

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
20 years-old <=
Age-upper limit
49 years-old >=
Gender Male and Female
Key inclusion criteria 1) Japanese.
Age >=20 and <=49 years.
2) Informed consent provided
3) Able to follow the instructions of the study team
Key exclusion criteria 1) Serious disorder
2) Regular hospital visit and medication intended to cure
3) Women who are or may be pregnant and who are lactating
4) Subjects judged by the investigator/project leader to be ineligible for other reasons
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takuya Mori
Organization Kao Corporation
Division name Biological Science Research
Zip code
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL 0285-68-7769
Email mori.takuya@kao.com

Public contact
Name of contact person
1st name
Middle name
Last name Yoshitaka Koga
Organization Kao Corporation
Division name Biological Science Research
Zip code
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL 0285-68-7613
Homepage URL
Email koga.yoshitaka@kao.com

Sponsor
Institute Kao Corporation
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
Address
Tel
Email

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 花王株式会社(栃木県)

Other administrative information
Date of disclosure of the study information
2019 Year 01 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
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
2018 Year 12 Month 19 Day
Date of IRB
2018 Year 12 Month 19 Day
Anticipated trial start date
2019 Year 01 Month 16 Day
Last follow-up date
2019 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information General survey to reveal the relevance between biological barrier and morbidity of infection.

Management information
Registered date
2019 Year 01 Month 15 Day
Last modified on
2019 Year 07 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040497

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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