Safety long-term study of drink-A containing lactic acid bacteria
- Conditions
- Healthy adult
- Registration Number
- JPRN-UMIN000031676
- Lead Sponsor
- APO PLUS STATION CO., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
1)Subjects with serious liver disease, renal / heart disease, organ disorder, diabetes, food allergy, gastrointestinal disease, other serious diseases 2)Subjects allergic to a specific drug or food 3)Subjects allergic to samples in this study 4)Pregnants, lactating women or who is going to be pregnant during study 5)Subjects drawn blood over 200mL last 1 month, or over 400mL last 3 months before consent acquisition date 6)Subjects who can't maintain everyday life habits 7)Subjects with a several variation of the amount of diet or movement 8)Subjects drink alcohol over 500mL in terms of beer per day 9)Subjects smoke over average 20 cigarettes per day 10)Subjects who can not refrain from using health foods, during the study 11)Subjects who can not take the test food as instructed 12)Subjects who have participated in the other clinical studies 13)Subjects judged as unsuitable for the study by the principal investigator for other reasons
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency of side effects
- Secondary Outcome Measures
Name Time Method Frequency of adverse events, Physical examination, Blood test, Urinalysis, Background factors, Lifestyle background