Healthy adult
Conditions
Interventions
Sponsors
EP Mediate Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Healthy males and females from 20 to 64 years of age (2)Subjects who are judged as ocular and nasal discomfort with Japanese cedar pollen by the investigator (3)Subjects who have positive for specific IgE against Japanese cedar pollen (4)Among the healthy subjects and those with mild symptoms, more than half of the enrolled subjects will be selected from healthy subjects Healthy subjects: Subjects suffering or having suffered from allergic reactions in their ocular and nasal and not using antiallergic drugs before and during the study period Subjects with mild symptoms: Subjects suffering or having suffered from allergic reactions in their ocular and nasal and sometimes used antiallergic drugs before and during the study period
Exclusion criteria
Exclusion criteria: (1)Subjects who are constantly using drugs or health food affecting nasal and ocular symptoms (2)Subjects who cannot limit the consumption of food or medicine containing lactic acid bacteria after informed consent (e.g., yogurt, beverage containing lactic acid bacteria or bifidobacterium, kimuchi or pickled foods etc.) (3)Subjects who frequently visit an otorhinology (4)Subjects who have acute rhinitis, nasal sinuses, hypertrophic rhinitis, or perennial allergy (5)Subjects who are complicated by bronchial asthma (6)Subjects who has under treatment or a history of serious disease (e.g., diabetes, liver disease, kidney disease, heart disease, respiratory disease, endocrine disease, or metabolic disease) (7)Subjects who are under mediation which may influence the outcome of the study (e.g. specific desensitization therapy) (8)Subjects having a disease requiring treatment or a history of serious diseases for which medication was required (9)Subjects who are engaged in drive a car or operate a hazardous machine (10)Subjects judged as unsuitable for the study based on the results of clinical examination or cardiopulmonary abnormality in the past (11)Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (12)Subjects having possibilities for emerging allergy related to the study (13)Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (14)Subjects who have participated in other clinical studies (15)Subjects who intend to become pregnant or lactating (16)Subjects judged as unsuitable for the study by the investigator for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| QOL questionaries during exposure to Japanese cedar pollen in an environmental exposure unit | — |
Secondary
| Measure | Time frame |
|---|---|
| (1)QOL questionaries after exposure to Japanese cedar pollen in an environmental exposure unit (2)eosinophil of nasal mucus (3)medical examination for check subjects nasal condition (4)allergic rhinitis severity classification (5)intestinal flora | — |
Countries
Japan
Contacts
Public ContactTamaki Furuhata
EP Mediate Co., Ltd. Development Business Headquarters, TTC Center, Trial Planning Department
Outcome results
None listed