none
Conditions
Interventions
50 mg of Lactic Acid Bacteria, once-daily for 12 weeks
50 mg of placebo, not including Lactic Acid Bacteria, once-daily for 12 weeks
Sponsors
TES Holdings Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and Female aged from 20 to 64 years, when giving the informed consent. 2. Healthy individuals not having any chronic diseases. 3. Individuals with allergic reaction of eyes and nose in early spring. 4. Individuals with detectable levels of cedar pollen-specific IgE in serum. 5. Individuals who give the informed consents in writing, after receiving enough explanation of the purpose and details of the study, understanding the study well, and deciding to attend the study with their own will. 6. Individuals who can accomplish their tasks in the study at the appointed date. 7. Individuals who are judged suitable for this study by the investigator.
Exclusion criteria
Exclusion criteria: 1. Individuals who have some diseases with drug therapy. 2. Individuals who use antiallergic drugs or steroid drugs or will use during the test period. 3. Individuals who have history of intranasal laser therapy or sublingual immunotherapy to reduce allergic symptoms. 4. Individuals who are a patient of or have a history of asthma. 5. Individuals who are patient or have a history of mental disease, psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. 6. Individuals who consecutively receive drugs for treatment of disease in the last 1 month. 7. Individuals who could have severe allergy to foods or drugs. 8. Individuals who have severe disease histories in liver, kidney, heart, lung, blood or the other tissues. 9. Individuals who are a patient or have a history of endocrine disease. 10. Individuals whose BMI is over 30 kg/m2 11. Individuals who have donated over 200 mL of blood in the last 1 month or 400 mL of blood in the last 3 months. 12. Individuals who cannot stop to ingest yogurt, or drugs or supplements including Lactic acid bacteria or bifidobacterium during the test period. 13. Individuals who had a habit to ingest bifidobacterium-rich foods, health-promoting foods, health foods, or supplements containing similar composition with a test food or will ingest those foods during the test period. 14. Individuals who generally intake alcohol drinks over 60 g/day as the amount of pure alcohol. 15. Individuals who could change their location and their life style during the study, e.g. business trip or traveling for a long time. 16. Individuals who are pregnant, breastfeeding, or planning to be pregnant in the near future. 17. Individuals who participated in other clinical trials in the last 3 months. 18. Individuals who and whose family work for a company manufacturing or selling healthy foods, functional foods. 19. Individuals who are judged unsuitable for this study by the investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| <Efficacy> The discomfort of eyes and nose in the daily life (Japan Rhinitis Quality of Life Questionnaire No. 1, grading the severity of allergic rhinitis) | — |
Secondary
| Measure | Time frame |
|---|---|
| <Efficacy> Indexes for allergic rhinitis (grading of local findings, eyes and nose condition based on subject's diary, effect measurement), specific measurement of blood, specific measurement of nasal discharge <Safety> Blood pressure, pulse, body weight, body fat percentage, body mass index, hematology test, biochemical test, urinalysis, assessment of adverse events by a medical doctor. <Other indexes> Subject's diary, questionnaire for allergic rhinitis, height measurement | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd Administrative Department of Clinical Trials
Outcome results
None listed