Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Tablet containing lactic acid bacilli Administration: Take two tablets daily at any time with water or lukewarm water *If you forget to take the test food, take it a
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy subjects or those with mild cedar pollen subjects 5. Subjects who have had various symptoms of cedar pollinosis (sneezing, runny nose, stuffy nose, or itchy eyes) in the past two years 6. Subjects who have not developed cedar pollinosis at the time of obtaining consent 7. Subjects who have received a sufficient explanation of the purpose and content of the study, have the ability to consent, have a good understanding of the subject, voluntarily apply for participation, and agree in writing to participate in the study
Exclusion criteria
Exclusion criteria: 1. Subjects receiving treatment for perennial rhinitis 2. Subjects undergoing specific sensitization therapy or surgical therapy for hay fever 3. Subjects who use or take steroidal drugs for drug treatment of hay fever 4. Subjects who reported nasal disease (acute or chronic rhinitis, sinusitis, rhinophyma, hypertrophic rhinitis, or nasal septal deformity) 5. Subjects who have been reported as severe or most severely ill in the severity assessment of allergic rhinitis 6. Subjects suffering from certain diseases except hay fever and receiving outpatient medication 7. Subjects with a history or current history of serious hepatic disorder, renal disorder, cardiac disease, or severe anemia 8. Subjects with a current history of bronchial asthma or those taking anti-allergy medication for atopic dermatitis, asthma, etc. 9. Subjects who may show allergic symptoms to any of the research food ingredients 10. Subjects who who take medicines (such as lactobacillus preparations) that may affect test results, or who routinely consume health foods 11. Subjects with gastrointestinal diseases affecting digestion and absorption, and persons with a history of gastrointestinal surgery 12. Subjects who habitually drink excessive amounts of alcohol, exceeding approximately 60 g of pure alcohol equivalent per day, five or more days per week 13. Subjects with extremely irregular eating habits, shift workers, late-night workers, or those with irregular life rhythms 14. Pregnant, lactating, or intending to become pregnant 15. Subjects who have donated more than 200 mL of blood or component blood within 4 weeks of the screening test or 400 mL within 3 months of the screening test 16. Subjects who have participated in other studies within 1 month of obtaining consent, and those who are willing to participate 17. Subjects who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The Japanese allergic rhinitis quality of life questionnaire 2. The grading severity of allergic rhinitis questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Local findings in nasal cavity 2. Cedar pollen-specific IgE antibody levels 3. Eosinophils, LD(IFCC) | — |
Countries
Japan
Contacts
Public ContactYoshika Komori
KSO Corporation Clinical Trial Management department
Outcome results
None listed