UMIN-CTR Clinical Trial

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
Email	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
Email	hnanri@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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045385