Healthy adults
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Japanese males and females aged 20 to 59 years old at the time of acquiring consent on the first observation day (including screening) 2) Persons who have 3 to 5 times of bowel movement per week
Exclusion criteria
Exclusion criteria: 1) Persons who are taking medications (antibiotics, drugs with intestinal action, etc.) that are likely to affect the test results 2) Persons routinely taking health foods (such as supplements expressing intestinal action, etc.) that are likely to affect the test results 3) During pregnancy or possibly pregnant, and those who are breastfeeding 4) Alcohol addiction 5) Persons who are likely to have allergic symptoms depending on the test article component 6) Participating in other clinical trials 7) Persons who have a history of serious liver disorder, kidney disorder, heart disease 8) Persons who have a history of hepatitis or who are currently suffering from hepatitis 9) Persons with serious anemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bowel survey (bowel movement, feculent) | — |
Secondary
| Measure | Time frame |
|---|---|
| Intestinal flora analysis Fecal organic acids analysis Fecal spoilage product analysis Fecal ammonia measurement Fecal pH measurement Fecal water content measurement Intestinal flora analysis (quantitative PCR) 6 primer | — |
Countries
Japan
Contacts
SOUKEN Co., Ltd Management Division