UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063124 |
|---|---|
| Receipt number | R000072257 |
| Scientific Title | Exploratory study on the effects of consuming lactic acid bacteria on mental health |
| Date of disclosure of the study information | 2026/09/30 |
| Last modified on | 2026/09/30 18:13:35 |
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Basic information
Public title
Exploratory study on the effects of consuming lactic acid bacteria on mental health
Acronym
Exploratory study on the effects of consuming lactic acid bacteria on mental health
Scientific Title
Exploratory study on the effects of consuming lactic acid bacteria on mental health
Scientific Title:Acronym
Exploratory study on the effects of consuming lactic acid bacteria on mental health
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the effects of 4-week consumption of foods containing live or killed lactic acid bacteria on mental health, compared with a placebo food
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
- Subjective assessment (Stress, Anxiety, Mental/Vitality, Well-being, Sleep)
- Salivary psychological stress markers
- Blood intestinal barrier and inflammatory markers
- Fecal microbiota
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral intake of 1 g of powder containing live lactic acid bacteria once daily for 4 weeks
Interventions/Control_2
Oral intake of 1 g of powder containing killed lactic acid bacteria once daily for 4 weeks
Interventions/Control_3
Oral intake of 1 g of powder without lactic acid bacteria once daily for 4 weeks
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
| 30 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Healthy working adults aged 30 years or older and younger than 65 years at the time of obtaining consent
2.Subjects who feel stress in their daily work or life and routinely experience anxiety or mental fatigue
3.Subjects who can give informed consent to partake in this study, after being provided with an explanation of the protocol detail
Key exclusion criteria
1.Subjects with a history of gastric of lower gastrointestinal surgery (without hemorrhoid surgery, polypectomy, and appendectomy)
2.Subjects who participated in another clinical study within 1 month before informed consent, are currently participating in one, or plan to do so during the study period
3.Subjects scheduled for an upper gastrointestinal barium X-ray, small intestinal endoscopy, colonoscopy, or colon cleansing (at a clinic or at home) between screening and the end of the study
4.Subjects planning to use, even once, medications that may affect the study between screening and the end of the study
5.Subjects with a Self-Rating Depression Scale (SDS) score of 60 or higher
6.Subjects with a current or past psychiatric disorder, or receiving treatment, medication, lifestyle guidance, or counseling for one
7.Subjects with other serious or progressive diseases
8.Subjects unable to stop consuming foods or supplements that may affect the study between screening and the end of the study
9.Smokers
10.Subjects consuming more than 40 g of pure alcohol per day on average
11.Subjects with irregular daily rhythms due to night or shift work
12.Subjects expecting major changes in their home or work environment (e.g., relocation, job transfer, or job change) during the study period
13.Subjects planning overseas travel, or travel or business trips longer than 1 week, during the study period
14.Subjects with self-perceived severe menstrual symptoms (e.g., physical discomfort, depressed mood, irritability, or anxiety)
15.Subjects who are pregnant, breastfeeding, or planning pregnancy during the study period
16.Subjects with food allergies
17.Subjects judged ineligible by the principal investigator
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Nakamura |
Organization
Meiji Co., Ltd.
Division name
R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji, Tokyo, Japan
TEL
042-623-5847
kentarou.nakamura@meiji.com
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ichinohe |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
Meiji Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Meiji 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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
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
チヨダパラメディカルケアクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 21 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 21 | 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 | 09 | Month | 30 | Day |
Last modified on
| 2026 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072257
