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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000039798
Receipt No. 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 2020/03/12

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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 Haruka
Middle name
Last name Murakami
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
Email haruka-m@nibiohn.go.jp

Public contact
Name of contact person
1st name Haruka
Middle name
Last name Murakami
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
Email haruka-m@nibiohn.go.jp

Sponsor
Institute National Institutes of Biomedical Innovation, Health and Nutrition
Institute
Department

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
Email 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
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
2020 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045385

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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