UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055645 |
|---|---|
| Receipt number | R000063073 |
| Scientific Title | Exploratory Study on the Effects of Lactobacillus Consumption on Mental Health |
| Date of disclosure of the study information | 2024/09/27 |
| Last modified on | 2025/10/27 15:45:28 |
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Basic information
Public title
Exploratory Study on the Effects of Lactobacillus Consumption on Mental Health
Acronym
Exploratory Study on the Effects of Lactobacillus Consumption on Mental Health
Scientific Title
Exploratory Study on the Effects of Lactobacillus Consumption on Mental Health
Scientific Title:Acronym
Exploratory Study on the Effects of Lactobacillus Consumption on Mental Health
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effects of continuous consumption of test food for 4 weeks on mental health, compared to the consumption of a control food.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
- Bacterial count of each gut microbiota species in feces
- Occupancy rate of each gut microbiota species in feces
- Salivary chromogranin A and oxytocin
- Blood levels of zonulin, LBP, IL-6, TNF-alpha, high-sensitivity CRP, BDNF, L-DOPA, and 5-HTP
- Questionnaires
Performance-related indicators: WHO-HPQ (short form, Japanese version)
Stress-related indicators: State-Trait Anxiety Inventory-Form JYZ (STAI), Brief Job Stress Questionnaire (57-item version), Chalder Fatigue Questionnaire Japanese version, Subjective Vitality Scale Japanese version (SVS-J)
Well-being indicators: Cantril's Ladder, Japanese version of the Subjective Happiness Scale (SHS), Interdependent Happiness Scale (IHS)
Sleep-related indicators: Pittsburgh Sleep Quality Index Japanese version (PSQI), Oguri-Shirakawa-Azumi Sleep Inventory MA version (OSA-MA)
Gastrointestinal-related indicators: Izumo Scale
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consumption of the test food (1 bottle a day) for 4 weeks
Interventions/Control_2
Consumption of the placebo food (1 bottle a day) for 4 weeks
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Men and women aged 20 to 59 years at the time of consent acquisition.
2. Subjects who can give informed consent to partake in this study, after being provided with an explanation of the protocol detail.
3. Subjects who feel a decline in their work performance.
Key exclusion criteria
1. Subjects with a history of gastric or lower gastrointestinal surgery (excluding hemorrhoids and polypectomy).
2. Subjects scheduled to undergo gastric X-ray barium examination or small intestine/colon endoscopy at a clinic, or intestinal cleansing at a clinic or at home between the time of consent and the end of the trials.
3. Subjects planning to take or use medications that may affect the study (such as antibiotics, proton pump inhibitors (PPIs), diabetes medications (e.g., metformin), laxatives (e.g., magnesium oxide), or bile acid sequestrants (e.g., UDCA)) one or more times between the time of consent and the end of the trial.
4. Subjects scoring 50 or above on the Self-Rating Depression Scale (SDS).
5. Subjects with a history or current diagnosis of mental disorders, or those receiving treatment, medication, lifestyle guidance, or counseling for mental disorders.
6. Subjects who have smoking habit.
7. Subjects planning overseas travel, trips longer than one week, or business trips from one week before each intake period to the end of each intake period.
8. Subjects with allergies to food.
9. Females who are pregnant or lactating, and females who could become pregnant during trial period.
10. Subjects deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Fumiko |
| Middle name | |
| Last name | Nakamura |
Organization
CPCC Company Limited
Division name
Clinical Support Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
cpcc-contact@cpcc.co.jp
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
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Meiji Holdings Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Meiji Co., Ltd.
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 27 | 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
60
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
| 2024 | Year | 07 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 27 | Day |
Last modified on
| 2025 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063073
