UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059750 |
|---|---|
| Receipt number | R000068328 |
| Scientific Title | Research toward realizing well-being through the utilization of human microbiome-related information |
| Date of disclosure of the study information | 2025/12/25 |
| Last modified on | 2025/12/25 09:02:40 |
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Basic information
Public title
Research toward realizing well-being through the utilization of human microbiome-related information
Acronym
Research toward realizing well-being through the utilization of human microbiome-related information
Scientific Title
Research toward realizing well-being through the utilization of human microbiome-related information
Scientific Title:Acronym
Research toward realizing well-being through the utilization of human microbiome-related information
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of clinical screening methods that enable accurate and rapid detection of a great number of microorganisms
Development of mathematical analysis technique for understanding the relationship between lifestyle and microbiome
Development of personalized recommendations for the enhancing well-being
Basic objectives2
Others
Basic objectives -Others
Correlation analysis, etc.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gut Microbiome
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Users of gut microbiome testing services (Mykinso), oral microbiota testing services (Mykinso Oral), and related services.
Subjects who receive a sufficient briefing of the objective and content of the present study, fully understand and agree to voluntarily participate in the study. Alternatively, subjects for whom consent can be obtained from a legally authorized representative capable of inferring the subject's will.
Key exclusion criteria
Subjects deemed unsuitable by the principal investigator
Target sample size
300000
Research contact person
Name of lead principal investigator
| 1st name | Yousuke |
| Middle name | |
| Last name | Hara |
Organization
Cykinso, Inc.
Division name
Director
Zip code
1510053
Address
1-36-1 Yoyogi, Shibuya-ku
TEL
0353092522
yousuke.hara@cykinso.co.jp
Public contact
Name of contact person
| 1st name | Mykinso |
| Middle name | |
| Last name | Support desk |
Organization
Cykinso, Inc.
Division name
Mykinso Support desk
Zip code
1510053
Address
1-36-1 Yoyogi, Shibuya-ku
TEL
05031969123
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
The University of Osaka Bioinformatics Center Infection Metagenomics
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku
Tel
0354081599
shiba_palace@s-palace-clinic.com
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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 25 | 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
| 2025 | Year | 10 | Month | 09 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Examining the relationship between microbiome and lifestyle
Management information
Registered date
| 2025 | Year | 11 | Month | 12 | Day |
Last modified on
| 2025 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068328
