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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036611
Receipt No. R000041707
Scientific Title Exploratory investigation of relationships between microbiota and healthy states
Date of disclosure of the study information 2019/05/08
Last modified on 2019/06/27

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Basic information
Public title Exploratory investigation of relationships between microbiota and healthy states
Acronym Exploratory investigation of relationships between microbiota and healthy states
Scientific Title Exploratory investigation of relationships between microbiota and healthy states
Scientific Title:Acronym Investigation of microbiota and health
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate relationships between healthy states and gut bacteria or their metabolites.
Basic objectives2 Others
Basic objectives -Others Not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Not applicable
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Subjects who have given written informed consent
2) Subjects are enrolled at R&D Div. Meiji Co., Ltd.
Key exclusion criteria 1) Subjects who are pregnant

Target sample size 50

Research contact person
Name of lead principal investigator
1st name Seiya
Middle name
Last name Makino
Organization Meiji Co., Ltd.
Division name Food Microbiology Research Laboratories, R&D Division
Zip code 192-0919
Address 1-29-1 Nanakuni, Hachiouji, Tokyo
TEL 042-632-5838
Email seiya.makino@meiji.com

Public contact
Name of contact person
1st name Seiya
Middle name
Last name Makino
Organization Meiji Co., Ltd.
Division name Food Microbiology Research Laboratories, R&D Division
Zip code 192-0919
Address 1-29-1 Nanakuni, Hachiouji, Tokyo
TEL 042-632-5838
Homepage URL
Email seiya.makino@meiji.com

Sponsor
Institute Food Microbiology Research Laboratories, R&D Div., Meiji Co., Ltd.
Institute
Department

Funding Source
Organization Food Microbiology Research Laboratories, R&D Div., Meiji Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Meiji IRB
Address 1-29-1 Nanakuni, Hachiouji, Tokyo, 192-0919
Tel 042-632-5900
Email MEIJI.IRB@meiji.com

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
2019 Year 05 Month 08 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
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
2019 Year 04 Month 19 Day
Date of IRB
2019 Year 04 Month 19 Day
Anticipated trial start date
2019 Year 05 Month 08 Day
Last follow-up date
2019 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2021 Year 03 Month 31 Day

Other
Other related information Gut microbiota, Contens of feces, Physical examinations, blood examinations, Balance of autonomic nervous system, gastrointestinal symptoms, Degree of fatigue, Quality and quantity of Sleep, Degrees of stress, Lifestyle, Eating habit.

Management information
Registered date
2019 Year 04 Month 26 Day
Last modified on
2019 Year 06 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041707

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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