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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035548
Receipt No. R000040309
Scientific Title Acquisition of intestinal environment data through the individual intestinal environment evaluation service
Date of disclosure of the study information 2019/01/16
Last modified on 2019/01/15

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Basic information
Public title Acquisition of intestinal environment data through the individual intestinal environment evaluation service
Acronym Acquisition of intestinal environment data through the individual intestinal environment evaluation service
Scientific Title Acquisition of intestinal environment data through the individual intestinal environment evaluation service
Scientific Title:Acronym Acquisition of intestinal environment data through the individual intestinal environment evaluation service
Region
Japan

Condition
Condition Men and women
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Acquisition of intestinal environment data through the evaluation service provided by Metabologenomics, Inc.
Basic objectives2 Others
Basic objectives -Others Research
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Intestinal environment evaluation based on microbiota analysis and metabolomics analysis
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) User of intestinal environment evaluation service or related services provided by Metabologenomics, Inc.
2) Subjects who show understanding of the study procedures and agreement with participating the study by written informed consent appeared on website of Metabolognomics, Inc. prior to the study. In case of minor and/or person who don't have ability to agree, the agreement by substitute person is necessary.
3) If the subjects are minor and/or person who don't have ability to conduct the collection of sample and answering questionnaire by themselves, appropriate person to support or substitute their operation is necessary.
Key exclusion criteria 1) Subjects who may have difficulty to collect the stool along the procedure instructed by Metabologenomics, Inc.
2) Subjects with suspected infection.
3) Subjects who have been determined as ineligible for participating the research by principal investigator.
Target sample size 100000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinji Fukuda
Organization Metabologenomics, Inc.
Division name Headquarters
Zip code
Address C-17,18, 246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan
TEL +81-235-64-0330
Email research@metagen.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinosuke Murakami
Organization Metabologenomics, Inc.
Division name Headquarters
Zip code
Address C-17,18, 246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan
TEL +81-235-64-0330
Homepage URL
Email mgnavi@metagen.co.jp

Sponsor
Institute Metabologenomics, Inc.
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 01 Month 16 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 Preinitiation
Date of protocol fixation
2018 Year 10 Month 04 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This research is aimed at acquiring the various intestinal environments data from people who use the intestinal environment evaluation service or related services provided by Metabologenomics, Inc.

Management information
Registered date
2019 Year 01 Month 15 Day
Last modified on
2019 Year 01 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040309

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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