UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040359 |
|---|---|
| Receipt number | R000046037 |
| Scientific Title | Changes in gut and oral microbiome associated with dental treatment |
| Date of disclosure of the study information | 2020/05/11 |
| Last modified on | 2024/02/16 08:32:13 |
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Basic information
Public title
Changes in gut and oral microbiome associated with dental treatment
Acronym
Mykinso Oral
Scientific Title
Changes in gut and oral microbiome associated with dental treatment
Scientific Title:Acronym
Mykinso Oral
Region
| Japan |
Condition
Condition
Anyone 16 years of age or older who has visited Tsujimura Dental Clinic and has agreed to undergo microbiome test.
Classification by specialty
| Dental medicine | Adult |
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 and saliva 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 and oral health
Basic objectives2
Others
Basic objectives -Others
We will analyze a large number of specimens quickly, accurately, and at a low cost, and find statistical correlations of questionnaire information on lifestyle and disease history obtained from research subjects, with the goal of acquiring knowledge that will help prolong healthy life expectancy.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gut Microbiome
Oral Microbiome
Key secondary outcomes
case registration form
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who have been fully briefed by institutional personnel in writing and orally about the research and have obtained consent in writing.
Key exclusion criteria
Not applicable
Target sample size
10000
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
Cykinso, 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
Tsujimura Dental Clinic, 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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 05 | Month | 11 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A bacterial flora database will be constructed, and lifestyle information on the study subjects will be obtained using dental examination data and questionnaires, and the correlation with information on resident bacteria will be verified.
Management information
Registered date
| 2020 | Year | 05 | Month | 11 | Day |
Last modified on
| 2024 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046037
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
