UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048517 |
|---|---|
| Receipt number | R000055271 |
| Scientific Title | A Study on the Effect of Plant-Derived Products on gut microbiota metabolites |
| Date of disclosure of the study information | 2022/07/29 |
| Last modified on | 2023/01/30 15:42:30 |
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Basic information
Public title
A Study on the Effect of Plant-Derived Products on gut microbiota metabolites
Acronym
A Study on the Effect of Plant-Derived Products on gut microbiota metabolites
Scientific Title
A Study on the Effect of Plant-Derived Products on gut microbiota metabolites
Scientific Title:Acronym
A Study on the Effect of Plant-Derived Products on gut microbiota metabolites
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effect of plant-derived products on gut microbiota metabolites in feces for subjects participated in A Study on the Effect of Plant-Derived Products on gut microbiome
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
gut microbiota metabolites
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Subjects who enrolled in A Study on the Effect of Plant-Derived Products on gut microbiome
2)Subjects who are giving written informed consent.
Key exclusion criteria
1)Subjects who are judged unsuitable for the study by the investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Iwama |
Organization
Nihonbashi Cardiology Clinic
Division name
Director
Zip code
103-0001
Address
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
TEL
03-5641-4133
yiwama@well-sleep.jp
Public contact
Name of contact person
| 1st name | Yoshika |
| Middle name | |
| Last name | Komori |
Organization
KSO Corporation
Division name
Sales department
Zip code
105-0023
Address
1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
yoshi@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
TOYO SHINYAKU 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
Ethical Committee of Nihonbashi Cardiology Clinic
Address
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
Tel
03-5641-4133
niho-jimucho@well-sleep.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
| 2022 | Year | 07 | Month | 29 | 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
| 2020 | Year | 12 | Month | 08 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 23 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is an additional study of A Study on the Effect of Plant-Derived Products on gut microbiome(UMIN ID: UMIN000043006)
Management information
Registered date
| 2022 | Year | 07 | Month | 29 | Day |
Last modified on
| 2023 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055271
