UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060829 |
|---|---|
| Receipt number | R000069455 |
| Scientific Title | The effect of the bifidobacterial probiotics X on the composition of gut microbiota and intestinal environment |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/03/05 10:11:21 |
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Basic information
Public title
The effect of the probiotics X on the composition of gut microbiota and intestinal environment
Acronym
The effect of the probiotics X on the composition of gut microbiota and intestinal environment
Scientific Title
The effect of the bifidobacterial probiotics X on the composition of gut microbiota and intestinal environment
Scientific Title:Acronym
The effect of the bifidobacterial probiotics X on the composition of gut microbiota and intestinal environment
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of probiotics X intake on the gut environment
Basic objectives2
Others
Basic objectives -Others
To examine the effect of probiotics X intake on the gut environment
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Abundance of the probiotics X in fecal samples, composition of gut microbiota
Key secondary outcomes
Gene expression profile of gut microbiota, fecal pH, organic acid concentration in fecal samples, analysis of fecal sugar composition, isolation of bacterial strain, metagenomic analysis, microbial metabolites, fecal IgA profile, side effects and adverse events
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
After the 1-week observation period, participants will consume a beverage containing probiotics X for 1 week, followed by a pause for 1 week. During the above periods, all participants are instructed to avoid consumption of probiotic products and yogurt.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy adults
Key exclusion criteria
Subjects with milk protein allergy
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Matsuki |
Organization
Yakult Central Institute
Division name
Basic Research Department
Zip code
186-8650
Address
Izumi 5-11, Kunitachi, Tokyo, Japan
TEL
042-577-8960
takahiro-matsuki@yakult.co.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Saito |
Organization
Yakult Central Institute
Division name
Basic Research Department
Zip code
186-8650
Address
Izumi 5-11, Kunitachi, Tokyo, Japan
TEL
042-577-8960
Homepage URL
yuki-saito@yakult.co.jp
Sponsor or person
Institute
Yakult Central Institute
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
Ethical committee of Yakult Central Institute
Address
Izumi 5-11, Kunitachi-shi, Tokyo, Japan
Tel
042-577-8960
takahiro-matsuki@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 | 04 | Month | 01 | 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
40
Results
Manuscript in preparation
Results date posted
| 2026 | Year | 03 | Month | 05 | 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
| 2019 | Year | 06 | Month | 27 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 27 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 22 | 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 | 03 | Month | 05 | Day |
Last modified on
| 2026 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069455
