UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory investigation of relationships between microbiota and health states
Acronym	Investigation of microbiota and health
Scientific Title	Exploratory investigation of relationships between microbiota and health 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	Completed
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	2021 Year 04 Month 07 Day

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