UMIN-CTR Clinical Trial

Basic information
Public title	Observational study of the effects of differences in hands and saliva ingredients on infectious diseases
Acronym	Effects of different ingredients on infectious diseases
Scientific Title	Observational study of the effects of differences in hands and saliva ingredients on infectious diseases
Scientific Title:Acronym	Effects of different ingredients on infectious diseases
Region	Japan

Condition
Condition	Healthy human
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the effects of differences in hands and saliva ingredients on infectious diseases
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence rate of acute upper respiratory tract 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	20 years-old <=
Age-upper limit	59 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy human
Key exclusion criteria	1, difficult to participate the study due to disorders of liver, kidney, heart, respiration, endocrine, metabolism, nerve, consciousness or diabetes, or the other disorders 2, medications or surgery for a disease or injury within 2 months before the study 3, Subjects who have been to get sick by collecting venous blood 4, the alcohol-intolerant subjects 5, Subjects who have had influenza since June 2019 6, pregnant 7, shift workers 8, attend or entry the other clinical study 9, judged to be inappropriate for the study by the medical doctor
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Koichi Middle name Last name Misawa
Organization	Kao Corporation
Division name	Biological Science Research
Zip code	131-8501
Address	2-1-3, Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
TEL	+81-3-5630-7268
Email	misawa.koichi@kao.com

Public contact
Name of contact person	1st name Nami Middle name Last name Yamanaka
Organization	Kao Corporation
Division name	Biological Science Research
Zip code	131-8501
Address	2-1-3, Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
TEL	+81-3-5630-7268
Homepage URL
Email	yamanaka.nami2@kao.com

Sponsor
Institute	Kao Corporation
Institute
Department

Funding Source
Organization	None
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	Ueno asagao clinic IRB
Address	2-7-5, Higashiueno, Taito-ku, Tokyo, JAPAN
Tel	+81-3-6240-1162
Email	jimukyoku@tes-h.co.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	2019 Year 10 Month 31 Day

Related information
URL releasing protocol	Unpublished due to the protocol including the intellectual property rights
Publication of results	Unpublished

Result
URL related to results and publications	works in progress
Number of participants that the trial has enrolled	399
Results	In the analysis
Results date posted	2021 Year 05 Month 07 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Healthy human
Participant flow	All participants completed the study
Adverse events	No adverse events occurred
Outcome measures	Incidence of infectious diseases
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 10 Month 30 Day
Date of IRB	2019 Year 10 Month 30 Day
Anticipated trial start date	2019 Year 11 Month 12 Day
Last follow-up date	2020 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	prospective observational study Recruit period: Oct-Nov,2019 400 people who fulfilled the criteria in the WEB survey were randomly extracted. blood, saliva, hands ingredients, diary

Management information
Registered date	2019 Year 10 Month 31 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=R000043820