UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029574
Receipt number 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 2020/03/24 23:28:10

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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-study

Scientific Title

Study for healthy-life expectancy using human microbiome-related information in an elderly Japanese population

Scientific Title:Acronym

Mykinso-KanagawaME-BYO-study

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 or person

Institute

Cykinso, Inc.

Institute

Department

Personal name



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

2020 Year 03 Month 24 Day



Link to view the page

Value
https://center6.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