UMIN-CTR Clinical Trial

Basic information
Public title	Changes in gut and oral microbiome associated with dental treatment
Acronym	Mykinso Oral
Scientific Title	Changes in gut and oral microbiome associated with dental treatment
Scientific Title:Acronym	Mykinso Oral
Region	Japan

Condition
Condition	Anyone 16 years of age or older who has visited Tsujimura Dental Clinic and has agreed to undergo microbiome test.
Classification by specialty	Dental medicine Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	(1) Developing a clinical screening method that enables accurate and rapid detection of a great number of microorganisms within a stool and saliva sample. (2) Developing mathematical analysis technique for understanding the relationship between lifestyle and bacterial flora (3) Developing the novel method of lifestyle advice based on one's gut and oral health
Basic objectives2	Others
Basic objectives -Others	We will analyze a large number of specimens quickly, accurately, and at a low cost, and find statistical correlations of questionnaire information on lifestyle and disease history obtained from research subjects, with the goal of acquiring knowledge that will help prolong healthy life expectancy.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Gut Microbiome Oral Microbiome
Key secondary outcomes	case registration form

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
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Interventions/Control_5
Interventions/Control_6
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Interventions/Control_10

Eligibility
Age-lower limit	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Those who have been fully briefed by institutional personnel in writing and orally about the research and have obtained consent in writing.
Key exclusion criteria	Not applicable
Target sample size	10000

Research contact person
Name of lead principal investigator	1st name Aya Middle name k. Last name Takeda
Organization	Cykinso, Inc.
Division name	Science unit
Zip code	151-0053
Address	Odaka Building, Yoyogi Shibuya 1-36-1, Tokyo, Japan
TEL	03-5309-2522
Email	takeda@cykinso.co.jp

Public contact
Name of contact person	1st name Satoshi Middle name Last name Watanabe
Organization	Cykinso, Inc.
Division name	Mykinso Support Desk
Zip code	151-0053
Address	Odaka Building, Yoyogi Shibuya 1-36-1, Tokyo, Japan
TEL	050-3196-9123
Homepage URL
Email	supportdesk@cykinso.co.jp

Sponsor
Institute	Cykinso, Inc.
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Tsujimura Dental Clinic, Japan
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Cykinso Research Ethics Committee
Address	Odaka Building, Yoyogi Shibuya 1-36-1, Tokyo, Japan
Tel	03-5309-2522
Email	science@cykinso.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	2020 Year 05 Month 11 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
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Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2020 Year 02 Month 20 Day
Date of IRB	2020 Year 02 Month 21 Day
Anticipated trial start date	2020 Year 05 Month 09 Day
Last follow-up date	2025 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	A bacterial flora database will be constructed, and lifestyle information on the study subjects will be obtained using dental examination data and questionnaires, and the correlation with information on resident bacteria will be verified.

Management information
Registered date	2020 Year 05 Month 11 Day
Last modified on	2020 Year 05 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046037

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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