Subjects with a tendency for constipation
Conditions
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese males and females aged from 20 and 64 years old 2. Subjects with bowel movements between 3 to 5 times a weeks at the point of screening examination 3. Subjects having an ability to understand study purpose and detail with voluntary written informed consent
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Lactobacilli in feces, butyric acid content in feces | — |
Secondary
| Measure | Time frame |
|---|---|
| Defecation survey, analysis of gut microbiota, organic acids content in feces, bile acids content in feces, pH and water content in feces, putrefactive product content in feces, ammonia content in feces, PAC-QOL Japanese version | — |
Countries
Japan
Contacts
Public ContactEiji Yoshikawa
KSO Corporation Sales department
Outcome results
None listed