UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028888 |
|---|---|
| Receipt number | R000033062 |
| Scientific Title | Study for healthy-life expectancy using human microbiome-related information (Mykinso-Pro) |
| Date of disclosure of the study information | 2017/09/01 |
| Last modified on | 2020/05/11 14:19:12 |
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Basic information
Public title
Study for healthy-life expectancy using human microbiome-related information (Mykinso-Pro)
Acronym
Mykinso-Pro
Scientific Title
Study for healthy-life expectancy using human microbiome-related information (Mykinso-Pro)
Scientific Title:Acronym
Mykinso-Pro
Region
| Japan |
Condition
Condition
Those who consented to take the gut microbiome test service at an institution (such as clinics and drugstores) using MykinsoPro service
Classification by specialty
| Medicine in general | Surgery in general | Dental medicine |
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 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
Oral 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
Those who consented to take the gut microbiome test service at an institution (such as clinics and drugstores) using MykinsoPro service.
Key exclusion criteria
Participants who have been determined ineligible by each institution.
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
takeda@cykinso.co.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Watanabe |
Organization
Cykiso, 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
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
03-5309-2522
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
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=R000033062
