Safety evaluation of overdose intake of foods containing Lactobacillus brevis subsp. coagulans (Labre)
- Conditions
- Healthy adults
- Registration Number
- JPRN-UMIN000052722
- Lead Sponsor
- Medical Corporation Hokubukai Utsukushigaoka Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 20
Not provided
(1) Subjects who have a history of heart, liver, kidney disease, organ damage, diabetes, or other serious diseases (2) Subjects who have a history of gastrointestinal surgery (excluding appendectomy) (3) Subjects who are currently receiving medical drug treatment (4) Subjects who are pregnant, wish to become pregnant during the study, or are breastfeeding (5) Subjects who take foods or supplements containing lactobacilli or bifidobacteria 3 times or more a week (Suguki pickle, bran pickle, kimchi, "Labre capsules", etc.) (6) Shift workers, including late-night shifts (7) Subjects who drink more than 60 g pure alcohol equivalent/day on average (8) Subjects who smoke an average of 21 cigarettes or more per day (9) Subjects who donated blood within 3 months at screening (10) Subjects who are participating in clinical research or monitoring (food, pharmaceuticals, cosmetics) other than this research, or plan to participate during this research period (11) Subjects who are judged to be inappropriate for this study with other reasons by the principal investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method