UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028887
Receipt number R000033061
Scientific Title Study for healthy-life expectancy using human microbiome-related information (Mykinso-Personal)
Date of disclosure of the study information 2017/09/01
Last modified on 2020/05/11 14:18:40

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Basic information

Public title

Study for healthy-life expectancy using human microbiome-related information (Mykinso-Personal)

Acronym

Mykinso-Personal

Scientific Title

Study for healthy-life expectancy using human microbiome-related information (Mykinso-Personal)

Scientific Title:Acronym

Mykinso-Personal

Region

Japan


Condition

Condition

Healthy volunteer

Classification by specialty

Adult Child

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

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Gut Microbiome

Key secondary outcomes

Life-style questionnaire


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Food Behavior,custom

Interventions/Control_1

dietary counseling or daily activity advice

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

An online cohort of self-reported healthy individuals who had submitted fecal samples through online gut microbiome testing service, Mykinso.

Key exclusion criteria

Participants who have medical conditions requiring dietary restrictions will be excluded.

Target sample size

100000


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

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 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

Cykinso Research Ethics Committee

Address

Odaka Building, Yoyogi Shibuya 1-36-1, Tokyo, Japan

Tel

050-3196-9123

Email

supportdesk@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

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 09 Month 01 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

Open public recruiting

Date of protocol fixation

2017 Year 08 Month 21 Day

Date of IRB

2017 Year 08 Month 21 Day

Anticipated trial start date

2017 Year 09 Month 01 Day

Last follow-up date

2025 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 08 Month 29 Day

Last modified on

2020 Year 05 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033061


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name