UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Study on the relevance between biological barrier and morbidity of infection.
Title of the study (Brief title)	A Study on the relevance between biological barrier and morbidity of infection.
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Infectious disease 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
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	110

Research contact person
Name of lead principal investigator	Takuya Mori
Organization	Kao Corporation
Division name	Biological Science Research
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	Yoshitaka Koga
Organization	Kao Corporation
Division name	Biological Science Research
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	University of Shizuoka
Name of secondary funｄer(s)

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	2018 Year 06 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 04 Month 18 Day
Anticipated trial start date	2018 Year 05 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	To reveal the effect of biological barrier on morbidity of infection

Management information
Registered date	2018 Year 05 Month 15 Day
Last modified on	2018 Year 07 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037168