Healthy Adults
Conditions
Interventions
The participants take 3 capsules containing the target lactic acid bacteria once a day for 12 weeks.
The participants take 3 capsules without the target lactic acid bacteria once a day for 12 weeks.
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese males and females aged 20 -64 years. 2. Participants who tend to catch a cold or get poor physical conditions. 3. Participants who received a sufficient explanation of the purpose and contents of this study, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document.
Exclusion criteria
Exclusion criteria: Participants (who) 1. suffering from, undergoing treatment for, or with a history of serious diseases 2. have chronic diseases and take medication on a daily basis 3. have been diagnosed with dry mouth 4. are unable to abstain from taking supplement, food for specified health use or functional food, or health food that may affect immune function 5. are unable to abstain from taking food that containing lactic acid bacteria, bifidobacterium, oligosaccharides, or viable bacteria during the study 6. consistently drink more than the appropriate amount of alcohol 7. are unable to abstain from alcohol for 2 days prior to the screening test and each test 8. have food allergies 9. take or plan to take medicine for pollen allergy 10. with digestive diseases affecting digestion and absorption and those with a history of digestive surgery (excluding appendicitis) 11. tend to get diarrhea by taking dairy products 12. are pregnant women, women who intend to become pregnant during the research period, and women who are breastfeeding 13. are judged to be inappropriate as research participants based on blood tests in the screening tests 14. have a history or current condition of drug or alcohol dependence 15. are participating in research involving the ingestion of other foods or the use of other medicines or those who have participated in or are willing to participate in other clinical research within one month of obtaining consent 16. are judged to be inappropriate as research participants by the principal investigator 17. smoke 21 or more cigarettes a day 18. plan to receive the influenza vaccine from 3 weeks before ingestion to the end of the ingestion period 19. plan to receive the COVID-19 vaccine during the ingestion period 20. work on night shift 21. plan to travel abroad during the study 22. has donated more than 200 mL of blood within 1 month or 400 mL of blood within 3 months prior to the date of obtaining consent, or those who have donated blood components
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A daily physical health questionnaire survey (about local and systemic symptoms associated with the common cold, general symptoms) | — |
Secondary
| Measure | Time frame |
|---|---|
| Salivary sIgA (concentration, secretion rate, secretion amount) NK cell activity Serum IgA level Serum IgG level pDC activity Body temperature Comprehensive analysis of intestinal microbiota POMS 2 Adult Forms | — |
Countries
Japan
Contacts
Public ContactEiji Yoshikawa
KSO Corporation Sales department
Outcome results
None listed