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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029574
Receipt No. R000033788
Scientific Title Study for healthy-life expectancy using human microbiome-related information in an elderly Japanese population
Date of disclosure of the study information 2017/10/20
Last modified on 2018/04/17

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Basic information
Public title Study for healthy-life expectancy using human microbiome-related information in an elderly Japanese population
Acronym Mykinso-KanagawaME-BYO
Scientific Title Study for healthy-life expectancy using human microbiome-related information in an elderly Japanese population
Scientific Title:Acronym Mykinso-KanagawaME-BYO
Region
Japan

Condition
Condition Healthy volunteer
Classification by specialty
Adult
Classification by malignancy Others
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 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 health
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes healthy-life expectancy
Key secondary outcomes Gut Microbiome
Life-style questionnaire

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
70 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria community-dwelling elderly persons aged 70 years or older in the Kanagawa area, Japan.
participants who gave informed consent.
Key exclusion criteria Participants who have been determined ineligible by each institution.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Aya Takeda
Organization Cykinso, Inc.
Division name Science unit
Zip code
Address Good Morning Building 301, Shibuya 2-6-6, Tokyo, Japan
TEL 03-3400-7476
Email takeda@cykinso.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Watanabe
Organization Cykinso, Inc.
Division name Support desk
Zip code
Address Good Morning Building 301, Shibuya 2-6-6, 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 Benno Laboratory, Innovation Center, RIKEN, Wako, Japan
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 株式会社サイキンソー(東京都)

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 20 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
2017 Year 10 Month 20 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 24 Day
Last follow-up date
2018 Year 03 Month 22 Day
Date of closure to data entry
2018 Year 03 Month 28 Day
Date trial data considered complete
2018 Year 04 Month 30 Day
Date analysis concluded
2018 Year 04 Month 30 Day

Other
Other related information Assessment
1. healthy-life expectancy
2. Gut Microbiome
3. Life-style questionnaire

Management information
Registered date
2017 Year 10 Month 16 Day
Last modified on
2018 Year 04 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033788

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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