UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050674 |
|---|---|
| Receipt number | R000057737 |
| Scientific Title | Clarifying the Relationship between Gastrointestinal Bacteria and Disease in the Japanese Population |
| Date of disclosure of the study information | 2023/03/31 |
| Last modified on | 2023/03/25 12:01:55 |
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Basic information
Public title
Clarifying the Relationship between Gastrointestinal Bacteria and Disease in the Japanese Population
Acronym
Clarifying the Relationship between Gastrointestinal Bacteria and Disease in the Japanese Population
Scientific Title
Clarifying the Relationship between Gastrointestinal Bacteria and Disease in the Japanese Population
Scientific Title:Acronym
Clarifying the Relationship between Gastrointestinal Bacteria and Disease in the Japanese Population
Region
| Japan |
Condition
Condition
health checkup recipient
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the characteristics of the gastrointestinal microbiota of the general public in Japan by analyzing the bacterial flora in saliva and feces of a population that includes a large number of healthy people who mainly receive physical examinations. We also aim to clarify the relationship between the gastrointestinal microbiota and the current medical history and oral condition, including the tongue, by evaluating the current medical history and oral condition.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to clarify the characteristics of the gastrointestinal microbiota of the general public in Japan by analyzing the bacterial flora in saliva and feces of a population that includes a large number of healthy people who mainly receive physical examinations. We also aim to clarify the relationship between the gastrointestinal microbiota and the current medical history and oral condition, including the tongue, by evaluating the current medical history and oral condition.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of salivary and fecal flora of medical checkup recipient
Key secondary outcomes
To classify the examinees according to the diseases diagnosed in their current medical history, and to determine whether the salivary and fecal flora are characteristic of each disease. We will determine whether there is a relationship between the salivary and fecal flora and the condition of the oral cavity as observed by intraoral photographs. We will also perform machine learning on the characteristics of intraoral photographs and bacterial flora, and analyze them using artificial intelligence. We will classify the examinees by the interview items, and clarify whether the salivary flora and fecal flora are characteristic of each item.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 20 years or older who visited Clinic MedCity21 during the period from after the head of the research institution gave permission for the research to be conducted to March 31, 2027.
Key exclusion criteria
Patients who are deemed ineligible for participation in the study by the physician in charge
Patients who do not consent to the use of the samples and information obtained in this study in the secondary use and reanalysis research that is planned to be conducted in the future.
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Nadatani |
Organization
Osaka Metropolitan University
Division name
Department of Premier Preventive Medicine
Zip code
545-8585
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL
81-6-6645-3946
dada@omu.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Nadatani |
Organization
Osaka Metropolitan University
Division name
Department of Premier Preventive Medicine
Zip code
545-8585
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL
81-6-6645-3946
Homepage URL
dada@omu.ac.jp
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Osaka Metropolitan University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Metropolitan University
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
Tel
06-6645-3456
gr-a-knky-ethics@omu.ac.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
| 2023 | Year | 03 | Month | 31 | 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
| 2023 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 03 | Month | 25 | Day |
Last modified on
| 2023 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057737
