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
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
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
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
