A Clinical Study for Evaluating the Safety of Long-Term Consumption and Excessive Consumption of Food Containing Microorganism -Open Study
- Conditions
- o
- Registration Number
- JPRN-UMIN000051000
- Lead Sponsor
- Oneness support Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 15
Not provided
1) Subjects who were diagnosed with serious disease (e.g., diabetes, liver disease, kidney disease, digestive disease, heart disease, respiratory disease and/or peripheral vascular disease). 2) Subjects who had a gastrointestinal surgery. 3) Subjects with abnormal parameters in liver and/or kidney function. 4) Subjects with a disease currently under treatment. 5) Subjects with drug or food allergies. 6) Subjects with anemic. 7) Women who are/might be pregnant or lactating during the current study periods. 8) Subjects who play high intensity sports and/or are on a diet. 9) Subjects with irregular life patterns. 10) Subjects who can't stop using functional foods (including Food for Specified Health Uses or Foods with Function Claims) and/or Specified quasi-drugs during the current study periods. 11) Subjects who are under treatment with medications (including OTC and/or prescribed medications). 12) Subjects who drink excessive alcohol. 13) Subjects who can't stop drinking from one day before each measurement. 14) Subjects who are participating in other studies or planning to participate at the start of the current study. 15) Subjects who are judged as unsuitable for the current study by doctors for other reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Doctor's questions, Physical measurement, Physical examination, Clinical examination(Hematological test, Blood biochemical test, Urinalysis), Adverse event
- Secondary Outcome Measures
Name Time Method