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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

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, Shinjuku, Tokyo, Japan

TEL

03-3203-8061

Homepage URL


Email

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

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

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


Research Plan
Registered date File name
2019/12/25 【R元年第3回】【健栄3-04】2_研究計画書・説明文書・同意書・同意撤回書.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name