UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058366 |
|---|---|
| Receipt number | R000066725 |
| Scientific Title | A randomized, placebo-controlled, double blind, parallel study to evaluate the effects of lactic acid bacteria on brain health and cognitive function in healthy children, |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/02/04 21:20:56 |
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Basic information
Public title
A study to evaluate the effects of lactic acid bacteria on brain health and cognitive function in healthy children,
Acronym
A study to evaluate the effects of lactic acid bacteria on brain health and cognitive function in healthy children,
Scientific Title
A randomized, placebo-controlled, double blind, parallel study to evaluate the effects of lactic acid bacteria on brain health and cognitive function in healthy children,
Scientific Title:Acronym
A randomized, placebo-controlled, double blind, parallel study to evaluate the effects of lactic acid bacteria on brain health and cognitive function in healthy children,
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The object of this study is to evaluate the effects of a 12-week continuous intake of the test food on cognitive functions related to memory and learning in healthy children who are native Japanese speakers and are third- and fourth-grade elementary school students attending regular classes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Executive function related to learning and memory, assessed by Digit Span, Go/No-Go task, and Stroop test
Key secondary outcomes
Autonomic nervous system activity (SDNN, LF, HF, LF/HF), Strengths and Difficulties Questionnaire (SDQ; parent-reported), Gut microbiota composition (T-RFLP analysis)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
12-week continuous intake of the test food containing lactic acid bacteria
Interventions/Control_2
12-week continuous intake of the placebo food without lactic acid bacteria
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
| 8 | years-old | <= |
Age-upper limit
| 10 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Subjects who are native Japanese speakers, currently enrolled in regular third- or fourth-grade elementary school classes at the time of consent (born between April 2, 2015 and April 1, 2017).
2) Subjects who are not receiving any medical treatment.
3) Subjects who are able to attend scheduled assessments and complete required records.
4) Subjects who, along with their legally authorized representatives (parents/guardians), have received sufficient explanation about the study and have voluntarily provided written informed consent.
Key exclusion criteria
1) Subjects who have been diagnosed with any neurodevelopmental disorders, intellectual disabilities, or other psychiatric conditions.
2) Subjects who have a history of serious disorders related to glucose metabolism, lipid metabolism, liver function, kidney function, heart, circulatory system, respiratory system, digestive system, endocrine system, immune system, or nervous system.
3) Subjects who have visual or auditory impairments or related disorders.
4) Subjects who have allergies to drugs or foods that may affect the study.
5) Subjects who are unable to refrain from consuming specified health foods, including Foods for Specified Health Uses (FOSHU), foods with functional claims, or other dietary supplements during the study period.
6) Subjects who are unable to consume the test food as instructed.
7) Subjects who are currently participating in another clinical trial or investigational study.
8) Subjects who are unable to follow the instructions of the principal investigator or are deemed unsuitable for participation by the principal investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Ueda |
Organization
Kaneka Corporation
Division name
Pharma & Supplemental Nutrition Solution Vehicle
Zip code
107-0052
Address
1-12-32, Akasaka, Minato-ku, Tokyo, Japan
TEL
03-3133-7349
Takahiro.Ueda@kaneka.co.jp
Public contact
Name of contact person
| 1st name | Soichi |
| Middle name | |
| Last name | Yoneda |
Organization
Mibyou Life Science Inc.
Division name
Clinical Trial Division
Zip code
101-0061
Address
5F Tokuei Bldg., Kanda Misaki-cho, Chiyoda-ku, Tokyo, Japan
TEL
03-6256-9600
Homepage URL
renraku@mibyou-ls.com
Sponsor or person
Institute
Mibyou Life Science Inc.
Institute
Department
Personal name
Funding Source
Organization
Kaneka Corporation
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
Mibyou Research Ethics Review Committee
Address
2-18-4 Kandamisakicho,Chiyoda-ku, Tokyo
Tel
03-6272-9163
renraku@npo-mibyou.com
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
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
| 2025 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 19 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 03 | Day |
Last modified on
| 2026 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066725
