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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000040359 |
Receipt No. | 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 | 2020/05/11 |
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 |
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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 |
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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 | |
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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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 | |
Institute | Cykinso, Inc. |
Institute | |
Department |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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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 |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046037 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |