UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000035548 |
|---|---|
| Receipt number | 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 | 2020/01/15 10:16:20 |
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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 | Shinji |
| Middle name | |
| Last name | Fukuda |
Organization
Metabologenomics, Inc.
Division name
Headquarters
Zip code
997-0051
Address
246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan
TEL
+81-235-64-0330
research@metagen.co.jp
Public contact
Name of contact person
| 1st name | Shinosuke |
| Middle name | |
| Last name | Murakami |
Organization
Metabologenomics, Inc.
Division name
Headquarters
Zip code
997-0051
Address
246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan
TEL
+81-235-64-0330
Homepage URL
mgnavi@metagen.co.jp
Sponsor or person
Institute
Metabologenomics, Inc.
Institute
Department
Personal name
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
Chiyoda Paramedical Care Clinic
Address
3-3-5 Uchikanda, Chiyoda-ku, Tokyo
Tel
03-5297-5548
IRB@cpcc.co.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
| 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 10 | Month | 04 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2035 | Year | 12 | Month | 31 | Day |
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
| 2020 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_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 |
