UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023270 |
|---|---|
| Receipt number | R000026816 |
| Scientific Title | Epidemiological study for constructing database of intestinal immunity and flora for healthy Japanese population contributing to new prevention methods establishment of lifestyle-related diseases and allergic disease |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2021/07/27 10:34:01 |
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Basic information
Public title
Epidemiological study for constructing database of intestinal immunity and flora for healthy Japanese population contributing to new prevention methods establishment of lifestyle-related diseases and allergic disease
Acronym
Cohort study on gut immunity and microbiota in Japanese healthy population
Scientific Title
Epidemiological study for constructing database of intestinal immunity and flora for healthy Japanese population contributing to new prevention methods establishment of lifestyle-related diseases and allergic disease
Scientific Title:Acronym
Cohort study on gut immunity and microbiota in Japanese healthy population
Region
| Japan |
Condition
Condition
lifestyle-related diseases and allergic disease
Classification by specialty
| Medicine in general | Gastroenterology | Cardiology |
| Endocrinology and Metabolism | Clinical immunology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The primary purpose of this study is to build the database on gut immunity and microbiota of healthy Japanese population.
Basic objectives2
Others
Basic objectives -Others
The secondary purpose is to clarify the associations among lifestyle, gut microbiota, and onset of diseases.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
lifestyle-related diseases and allergic 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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adult men and women who agreed to study participants
Key exclusion criteria
Persons with severe disease or without independent living
Target sample size
1200
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, 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, Shinjuku, Tokyo, Japan
TEL
03-3203-8061
Homepage URL
hnanri@nibiohn.go.jp
Sponsor or person
Institute
Department of Physical Activity Research, National Institutes of Biomedical Innovation, Health and Nutrition
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour, and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Coordination Office, Research Ethics Review Committee, National Institute of Biomedical Innovation, Health, and Nutrition
Address
7-6-8 Asagi, Saito-Nishi, Ibaraki, Osaka
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
| 2016 | Year | 08 | Month | 01 | 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
Analizing
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
| 2015 | Year | 09 | Month | 07 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2023 | 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
| 2016 | Year | 07 | Month | 21 | Day |
Last modified on
| 2021 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026816
