UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036611 |
|---|---|
| Receipt number | R000041707 |
| Scientific Title | Exploratory investigation of relationships between microbiota and health states |
| Date of disclosure of the study information | 2019/05/08 |
| Last modified on | 2021/04/07 11:07:33 |
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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
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
seiya.makino@meiji.com
Sponsor or person
Institute
Food Microbiology Research Laboratories, R&D Div., Meiji Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041707
