UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061586 |
|---|---|
| Receipt number | R000070459 |
| Scientific Title | Effect of synbiotics intake on intestinal environment and gut microbiota |
| Date of disclosure of the study information | 2026/05/31 |
| Last modified on | 2026/05/15 15:14:24 |
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Basic information
Public title
Effect of synbiotics intake on intestinal environment and gut microbiota
Acronym
Effect of synbiotics intake on intestinal environment and gut microbiota
Scientific Title
Effect of synbiotics intake on intestinal environment and gut microbiota
Scientific Title:Acronym
Effect of synbiotics intake on intestinal environment and gut microbiota
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of intervention of synbiotics on gut microbiota and intestinal environment.
Basic objectives2
Others
Basic objectives -Others
To investigate the effects of intervention of synbiotics on gut microbiota and intestinal environment.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Metabolites of gut bacteria
Key secondary outcomes
Gut microbiota composition
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Four week intervention of synbiotics (Three times per day)
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
Subjects having an ability to understand study purpose and detail with voluntary written informed consent.
Key exclusion criteria
Dairy allergy
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Matsui |
Organization
Yakult Central Institute
Division name
Pharmaceutical Research Department
Zip code
186-8650
Address
5-11 Izumi, Kunitachi, Tokyo, Japan
TEL
042-577-8970
ryo-matsui@yakult.co.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Konishi |
Organization
Yakult Central Institute
Division name
Pharmaceutical Research Department
Zip code
186-8650
Address
5-11 Izumi, Kunitachi, Tokyo, Japan
TEL
042-577-8970
Homepage URL
hiroaki-konishi@yakult.co.jp
Sponsor or person
Institute
Pharmaceutical Research Department, Yakult Central Institute
Institute
Department
Personal name
Funding Source
Organization
Pharmaceutical Research Department, Yakult Central Institute
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 Yakult Central Institute
Address
5-11 Izumi, Kunitachi, Tokyo, Japan
Tel
042-577-8960
kenta-suzuki@yakult.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
| 2026 | Year | 05 | Month | 31 | Day |
Related information
URL releasing protocol
Manuscript in preparation
Publication of results
Unpublished
Result
URL related to results and publications
Manuscript in preparation
Number of participants that the trial has enrolled
20
Results
manuscript in preparation
Results date posted
| 2026 | Year | 05 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
manuscript in preparation
Participant flow
manuscript in preparation
Adverse events
manuscript in preparation
Outcome measures
manuscript in preparation
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2025 | Year | 07 | Month | 21 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 29 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 15 | Day |
Last modified on
| 2026 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070459
