UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058797 |
|---|---|
| Receipt number | R000067225 |
| Scientific Title | Effects of lactic acid bacteria ingestion on subjective physical symptoms in healthy adult: A randomized, double-blind, placebo-controlled, parallel group comparison study. |
| Date of disclosure of the study information | 2025/08/13 |
| Last modified on | 2025/08/13 16:50:03 |
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Basic information
Public title
Effects of lactic acid bacteria ingestion on subjective physical symptoms in healthy adult: A randomized, double-blind, placebo-controlled, parallel group comparison study.
Acronym
Effects of lactic acid bacteria ingestion on subjective physical symptoms in healthy adults.
Scientific Title
Effects of lactic acid bacteria ingestion on subjective physical symptoms in healthy adult: A randomized, double-blind, placebo-controlled, parallel group comparison study.
Scientific Title:Acronym
Effects of lactic acid bacteria ingestion on subjective physical symptoms in healthy adults.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of lactic acid bacteria ingestion on subjective physical symptoms for healthy adult.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Subjective symptoms of physical conditions
Key secondary outcomes
Immunological parameters
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
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Daily ingestion of powdered lactic acid bacteria for 12 weeks.
Interventions/Control_2
Daily ingestion of placebo powder for 12 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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Healthy males and females who are aged 18-64 years at the time of obtaining consent.
2. Participants who fully understand the purpose and content of this study and agree to participate in this study with a written informed consent.
Key exclusion criteria
1. Participants with serious diseases such as malignant tumors, respiratory, liver, renal, cardiac, pulmonary, gastrointestinal, hematologic, endocrine, and metabolic diseases, or history of these disease.
2. Participants with atopic dermatitis, bronchial asthma, or chronic bronchitis.
3. Participants with mental illness or autoimmune diseases.
4. Participants receiving or planning treatment or medication for hay fever or allergic rhinitis.
5. Participants with serious drug/food allergies or a history of such allergies.
6. Participants who have oral bleeding during the study.
7. Participants pregnant, planning pregnancy during the study period, or breastfeeding.
8. Participants with BMI <17 or >=30 kg/m2.
9. Participants with a smoking habit.
10. Participants who regularly exceed the appropriate alcohol intake (20 g pure alcohol).
11. Participants who cannot abstain from alcohol for 2 days before evaluation.
12. Participants engaged in shift/night work, heavy labor, or go out less than 5 days/week.
13. Participants with an irregular lifestyle (e.g., frequently skips two meals/day).
14. Participants regular use (at least once/week) of drugs affecting immunity (e.g., antibiotics, steroids).
15. Participants regularly use immune-related supplements/functional foods, unable to stop during the study.
16. Participants unable to stop consuming foods with probiotics or oligosaccharides during the study.
17. Participants who have donated >200 mL blood in 1 month, or >400 mL in 3 months before consent.
18. Participants who have taken antibiotics within 4 weeks before screening.
19. Participants received a vaccination within 4 weeks prior to the screening, or plan to within 4 weeks before the 12-week exam.
20. Participants planning overseas travel during the study.
21. Participants who joined other clinical trials within 3 months before consent or planned during the study.
22. Participants judged ineligible to this study by principal investigator.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Tsuge |
Organization
Shinagawa Season Terrace Health Care Clinic
Division name
Doctor
Zip code
03-3452-3382
Address
Shinagawa Season Terrace 5F, 1-2-70 Konan, Minato-ku, Tokyo
TEL
03-3452-3382
shibaura@sempos.or.jp
Public contact
Name of contact person
| 1st name | Eriko |
| Middle name | |
| Last name | Yokoshima |
Organization
KSO Corporation
Division name
Clinical Trial Management department
Zip code
105-0023
Address
Shibaura Omodaka Building 7F, 1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO corporation
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry 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
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17 Joutou-machi,Maebashi-shi,Gunma
Tel
027-212-5608
sagawa@mc-connect.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
| 2025 | Year | 08 | Month | 13 | 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
| 2025 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | 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 | 08 | Month | 13 | Day |
Last modified on
| 2025 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067225
