A study for evaluating the effect of food containing lactic acid bacteria on relating nasal and ocular symptoms.
- Conditions
- Healthy adult
- Registration Number
- JPRN-UMIN000037571
- Lead Sponsor
- TTC Co., Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Not provided
(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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Subject's nasal or ocular symptom in an environmental exposure unit(EEU). (the number of sneezes and nose blowing, eye itching, watery eyes)
- Secondary Outcome Measures
Name Time Method 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.