None listed
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1)Japanese males and females aged of 20-64 years. 2)Subjects who defecate 2~5 times from the screening test per week. 3)Subjects who can visit on schedule days. 4)Subjects who recognize the object and contents of the study and submit the written informed consent.
Exclusion criteria
Exclusion criteria: 1)Subjects taking medicine laxatives or antibiotics. 2)Subjects unable to collect stool samples on the designated date. 3)Subjects taking pharmaceuticals (abortive medication is allowed). 4)Subjects with a history of serious liver, kidney, cardiovascular, gastrointestinal, pulmonary, blood, or metabolic disease. 5)Subjects who regularly use health foods and supplements affecting the study. 6)Subjects who are shift workers or graveyard shift workers. 7)Subjects with extremely irregular daily habits and eating habits. 8)Subjects who usually intake heavy amount of alcohol (40g alcohol/day>=) and who are excessive smoker(21 cigarettes/day>=). 9)Subjects who have systolic blood pressure <90 mmHg. 10)Subjects who feel bad mood by blood collection. 11)Subjects who donated 200 mL or more of blood within 1 month from the screening test. 12)Subjects already participating in other clinical trials. 13)Possible pregnancy, pregnancy and lactation. 14)Subjects who are ineligible due to physician's judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Defecation survey | — |
Secondary
| Measure | Time frame |
|---|---|
| Intestinal flora | — |
Countries
Japan
Contacts
New drug research center, Inc. Clinical Research Dept.