UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053849 |
|---|---|
| Receipt number | R000061458 |
| Scientific Title | Elucidation of the Relationship between Gastrointestinal Bacteria and Diseases in Japanese People |
| Date of disclosure of the study information | 2024/03/13 |
| Last modified on | 2024/03/13 17:08:18 |
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Basic information
Public title
Elucidation of the Relationship between Gastrointestinal Bacteria and Diseases in Japanese People
Acronym
Elucidation of the Relationship between Gastrointestinal Bacteria and Diseases in Japanese People
Scientific Title
Elucidation of the Relationship between Gastrointestinal Bacteria and Diseases in Japanese People
Scientific Title:Acronym
Elucidation of the Relationship between Gastrointestinal Bacteria and Diseases in Japanese People
Region
| Japan |
Condition
Condition
Healthy individuals
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the characteristics of the gastrointestinal microbiota in the so-called general population in Japan by analyzing the microbiota in saliva and feces, focusing on a group that includes many healthy individuals who undergo medical checkups. Additionally, by evaluating the current medical history and the condition of the oral cavity, including the tongue, the study seeks to elucidate the relationship between the current medical history, the condition of the oral cavity, and the gastrointestinal microbiota.
Basic objectives2
Others
Basic objectives -Others
This study aims to clarify the characteristics of the gastrointestinal microbiota in the so-called general population in Japan by analyzing the microbiota in saliva and feces, focusing on a group that includes many healthy individuals who undergo medical checkups. Additionally, by evaluating the current medical history and the condition of the oral cavity, including the tongue, the study seeks to elucidate the relationship between the current medical history, the condition of the oral cavity, and the gastrointestinal microbiota.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In this study, we mainly target a group that includes a large number of healthy individuals undergoing medical check-ups, and aim to clarify the characteristics of the gastrointestinal microbiota of the so-called general population in Japan by analyzing the bacterial flora in saliva and feces.
Key secondary outcomes
This research primarily targets a population comprising mostly healthy individuals who undergo comprehensive health checkups, with the aim of analyzing the bacterial flora in saliva and feces to elucidate the characteristics of the gastrointestinal microbiota among the so-called general populace in Japan. Furthermore, by evaluating the current medical history and the condition of the oral cavity, including the tongue, this study seeks to clarify the relationship between the current medical history, the state of the oral cavity, and the gastrointestinal microbiota.
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
individuals over the age of 20 who have visited the MedCity21, during the period from after the research institution's head grants permission for the study to March 31, 2027.
Key exclusion criteria
Individuals deemed ineligible by the attending physician.
Participants who do not consent to the secondary use and re-analysis of samples and information obtained from this study for subsequent research.
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
Premier Preventive medicine
Zip code
5458585
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka
TEL
06-6645-3946
dada@omu.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Nadatani |
Organization
Osaka Metropolitan university
Division name
Premier Preventive medicine
Zip code
5458585
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL
0666453946
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
Japan
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
dada@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
| 2024 | Year | 03 | Month | 13 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2028 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation Study
Management information
Registered date
| 2024 | Year | 03 | Month | 13 | Day |
Last modified on
| 2024 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061458
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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