A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study on Anti-Allergic Effects of Continuous Ingestion of Lactococcus lactis subsp. cremoris YRC3780
- Conditions
- Healthy adults
- Registration Number
- JPRN-UMIN000021215
- Lead Sponsor
- Hokkaido Information University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 96
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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