Healthy adult
Conditions
Interventions
Ingestion of food containing lactic acid bacteria for 8 consecutive weeks
Ingestion of placebo without lactic acid bacteria for 8 consecutive weeks
Sponsors
TTC Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Males and females from 20 to 64 years of age. (2)Subjects who complained of eye and nasal discomfort and judged tested positive for Japanese cedar pollen specific IgE. (3)Subjects who are judged as suitable for the study by the investigator. (4)Subjects who obtained the consent about participation in the study. (5)Subjects who do not take antiallergic drug account for more than half of whole.
Exclusion criteria
Exclusion criteria: (1)Subjects who routinely take food or medicine containing lactic acid bacteria or natto bacteria. (2)Subjects who have severe nasal and eye symptoms affecting judgement of discomfort. (3)Subjects who routinely take medicines affecting the test result. (4)Subjects who are under medication (specific desensitization therapy) which may influence the outcome of the study. (5)Subjects who are engaged in drive a car or operate a hazardous machine. (6)Subjects judged as unsuitable for the stuzy by the investigator for laboratory evidence or cardiopulmonary function. (7)Subjects who have a disease requiring regular medication or a history of serious disease for which medication was required. (8)Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination. (9)Subjects who are liable to cause an allergy related to the study. (10)Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire. (11)Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study. (12)Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating. (13)Subjects who are judged as unsuitable for the study by the investigator for other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subject's nasal or ocular symptom in an environmental exposure unit(EEU). (the number of sneezes and nose blowing, eye itching, watery eyes) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Visual analog scale(EEU) (nasal blockage, nasal itching, throat symptoms, sleepiness, disturbance of daily living) 2.Visual analog scale(after exposure Japanese cedar pollen) (the number of sneezes and nose blowing, nasal blockage, nasal itching, eye itching, watery eyes, throat symptoms, sleepiness, disturbance of daily living) 3.QOL questionnaire, diagnosis subject's noses, eosinophil of nasal mucus and skin questionnaire. | — |
Countries
Japan
Contacts
Public ContactChiharu Goto
TTC Co., Ltd. Clinical Research Planning Department
Outcome results
None listed