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

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 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

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

Value
https://center6.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