Healthy adults
Conditions
Interventions
Ingestion of capsules containing high-dose Lactococcus lactis subsp. cremoris YRC3780 daily for 12 weeks.
Ingestion of capsules containing middle-dose Lactococcus lactis subsp. cremoris YRC3780 daily
Sponsors
Hokkaido Information University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects suffering from nasal or ocular discomfort caused by white birch pollen. 2. Subjects who were positive for skin prick test to white birch pollen. 3. Subjects who agree to participate in this study with a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Subjects who have a past history of serious allergic reactions (anaphylaxis, etc.). 2. Subjects with acute rhinitis, sinusitis, nasal polyps, hypertrophic rhinitis and/or severely deviated nasal septum, etc. 3. Subjects with bronchial asthma. 4. Subject who are under immunotherapy such as specific desensitization therapy. 5. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, disorder of endocrine and metabolism or affected with infectious diseases which are required to report to the authorities. 6. Subjects who have a major surgical history related to digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc. 7. Subjects with abnormal blood pressure or hematological data. 8. Subjects with serious anemia. 9. Pre- or post-menopausal women with complaints of obvious physical changes. 10. Subjects with a history of allergy to medicine and/or food (especially milk and corn). 11. Subjects who regularly take drugs which may affect evaluation of the current study (antihistamines, anti-allergic drugs, steroids, vasoconstrictors, anti-inflammatory drugs, anti-rheumatic drugs, antibiotics, immunosuppressive drugs and/or lactobacillus preparation, etc.). 12. Heavy smokers, alcohol addicts or subjects with irregular lifestyle. 13. Subjects who donated either 400ml whole blood within 12 weeks or 200ml whole blood within 4 weeks or blood components within 2 weeks prior to the current study. 14. Pregnant or lactating women or women expect to be pregnant during the study. 15. Subjects who participate in other clinical trials within the last one month prior to this study. 16. Any other medical reasons judged by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total nasal symptom score, total ocular symptom score (Measurement time: Before starting the ingestion of test meals. 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 weeks after the ingestion of test meals. And 1 and 2 weeks after the end of ingestion of test meals.) | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptom score (sneezing, runny nose, stuffy nose, itchy eyes, watery eyes, throat symptoms and inconvenience for daily life), total symptom score, medication score, symptom-medication score (SMS), nasal SMS, ocular SMS, total IgE, white birch pollen-specific IgE, Th1/Th2 cytokine (IFN-gamma, IL-10), TARC, eosinophil count and WBC differential count | — |
Countries
Japan
Contacts
Public ContactDir. Prof. Jun NISHIHIRA, M.D., Ph.D.
Hokkaido Information University Health Information Science Center
Outcome results
None listed