UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039798 |
|---|---|
| Receipt number | R000045385 |
| Scientific Title | Epidemiological study for gut microbiome related to non-communicable disease in Minamiuonuma city |
| Date of disclosure of the study information | 2020/03/13 |
| Last modified on | 2021/03/23 17:15:25 |
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Basic information
Public title
Epidemiological study for gut microbiome related to non-communicable disease in Minamiuonuma city
Acronym
Gut microbiome study in Minamiuonuma city
Scientific Title
Epidemiological study for gut microbiome related to non-communicable disease in Minamiuonuma city
Scientific Title:Acronym
Gut microbiome study in Minamiuonuma city
Region
| Japan |
Condition
Condition
Non-communicable disease
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify the associations between gut microbiome and non-communicable disease
Basic objectives2
Others
Basic objectives -Others
To clarify the associations among lifestyle, gut microbiome, and onset of non-communicable disease
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Non-communicable disease
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
adults who take a annual health checkup examination in Minamiuonuma city
Key exclusion criteria
adults with inflammatory bowel disease
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Hinako |
| Middle name | |
| Last name | Nanri |
Organization
National Institutes of Biomedical Innovation, Health and Nutrition
Division name
Department of Physical Activity Research
Zip code
162-8636
Address
1-23-1 Toyama, Sinjuku-ku, Tokyo, Japan
TEL
03-3203-8061
hnanri@nibiohn.go.jp
Public contact
Name of contact person
| 1st name | Hinako |
| Middle name | |
| Last name | Nanri |
Organization
National Institutes of Biomedical Innovation, Health and Nutrition
Division name
Department of Physical Activity Research
Zip code
162-8636
Address
1-23-1 Toyama, Sinjuku-ku, Tokyo, Japan
TEL
03-3203-8061
Homepage URL
hnanri@nibiohn.go.jp
Sponsor or person
Institute
National Institutes of Biomedical Innovation, Health and Nutrition
Institute
Department
Personal name
Funding Source
Organization
Niigata Prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Coordination Office of Research Ethics
Address
Saito-Asagi, Ibaraki City, Osaka, Japan
Tel
072-641-9829
irb-office@nibiohn.go.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 | 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
625
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
| 2018 | Year | 04 | Month | 17 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 17 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
This study aim between lifestyle and gut microbiome, and to clarify to a new mechanism of onset of non-communicable disease through gut microbiome.
Management information
Registered date
| 2020 | Year | 03 | Month | 12 | Day |
Last modified on
| 2021 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045385
