UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058663 |
|---|---|
| Receipt number | R000067079 |
| Scientific Title | Investigation on diseases, constitutions, lifestyles, and gut microbiota associated with oral microbiota |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/08/01 08:00:34 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Investigation on diseases, constitutions, lifestyles, and gut microbiota associated with oral microbiota
Acronym
Investigation on diseases, constitutions, lifestyles, and gut microbiota associated with oral microbiota
Scientific Title
Investigation on diseases, constitutions, lifestyles, and gut microbiota associated with oral microbiota
Scientific Title:Acronym
Investigation on diseases, constitutions, lifestyles, and gut microbiota associated with oral microbiota
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between oral bacteria and diseases, constitution, lifestyle, and gut microbiota
Basic objectives2
Others
Basic objectives -Others
Correlation analysis
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between oral microbiota and questionnaire items
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
| 40 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Healthy Japanese men and women aged 40 to 70 at the time of obtaining consent.
2. Subjects who have 20 or more of their own teeth (not including implants).
3. 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.
Key exclusion criteria
1. Subjects who have used antibiotics within the past two months
2. Subject who undergoing orthodontic treatment
3. Subject who currently have a smoking habit (including e-cigarettes)
4. Female subjects who are pregnant or lactating, or intending to become pregnant during the study
5. Subjects who took part in another study within 3 months prior to the start of the present study or who is currently taking part in another study
6. Subjects deemed unsuitable by the principal investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Aya |
| Middle name | K. |
| Last name | Takeda |
Organization
Cykinso, Inc.
Division name
Director, co-Founder
Zip code
1510053
Address
1-36-1 Yoyogi, Shibuya-ku
TEL
03-5309-2522
takeda@cykinso.co.jp
Public contact
Name of contact person
| 1st name | Takayoshi |
| Middle name | |
| Last name | Fukushima |
Organization
Cykinso, Inc.
Division name
BtoB Division
Zip code
1510053
Address
1-36-1 Yoyogi, Shibuya-ku
TEL
03-5309-2522
Homepage URL
mykinsoresearch_mq03@cykinso.co.jp
Sponsor or person
Institute
Cykinso, Inc.
Institute
Department
Personal name
Funding Source
Organization
Lion Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
03-5408-1599
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 | 08 | 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
| 2025 | Year | 07 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Correlation between oral microbiota and disease, constitution, lifestyle, and gut microbiota
Management information
Registered date
| 2025 | Year | 08 | Month | 01 | Day |
Last modified on
| 2025 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067079
