A clinical study for evaluating the effects of food containing lactic acid bacteria on intestinal environment. - A randomized, double-blind, placebo-controlled, parallel-group comparative method
- Conditions
- Subjects with a tendency for constipation
- Registration Number
- JPRN-UMIN000048914
- Lead Sponsor
- KSO Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 80
Not provided
Subjects(who) 1. suffering from, undergoing treatment for, or with a history of serious diseases 2. have a chronic diseases and take medication on a daily basis 3. consume medication that potentially affect the intestinal environment on a daily basis 4. consume foods that potentially affect the intestinal environment more than 5 times a week 5. are unable to abstain from taking foods that potentially affect the intestinal environment. 6. have taken antibiotics within 2 weeks before the point of screening examination 7. perform high-intensity exercise intended for muscle building more than 3 times a week 8. smoke 21 or more cigarettes a day 9. have a history or current condition of drug or alcohol dependence 10. consistently drink more than the appropriate amount of alcohol 11. are planning major changes in their environment during the study period 12. with digestive diseases affecting digestion and absorption and with a history of digestive surgery 13. have food/ medication allergies 14. are judged to be inappropriate as subjects by background survey 15. are pregnant or breast-feeding, or have the will of pregnancy during the study period 16. are participating or are planning to participate in other clinical studies, and had participated within 1 month of obtaining informed consent 17. are judged to be inappropriate as subjects by screening examination 18. plan to travel abroad, including overseas travel, during the study period 19. are judged as inappropriate by investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method