Healthy adults
Conditions
Interventions
Daily ingestion of powdered lactic acid bacteria for 12 weeks.
Daily ingestion of placebo powder for 12 weeks.
Sponsors
KSO corporation
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective symptoms of physical conditions | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunological parameters | — |
Countries
Japan
Contacts
Public ContactEriko Yokoshima
KSO Corporation Clinical Trial Management department
Outcome results
None listed