People tend to be constipated
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. People whose defecation frequency is no fewer than 3 nor more than 5. 2. Who usually have three meals a day. 3. Who gave the informed consents in writing after receiving enough explanation of purpose and detail of the study, understanding the study well, and deciding to attend the study with their own will.
Exclusion criteria
Exclusion criteria: People who meet any of the following conditions will be excluded. 1. Who regularly use intestinal drugs and laxative (including strong laxatives and enema) 2. Who can not stop intake the health food to relive constipation (including Food for Specified Health Uses (FOSHU)) during the screening period. 3. Who use medicine such as antibiotics that affect digestion and absorption. 4. Who can not stop intake food containing viable bacteria such as Lactic acid bacteria, Bifidobacteria, Natto bacteria and/or enhanced with oligosaccharide, dietary fiber and/or the health food to relive constipation (including Food for Specified Health Uses (FOSHU)) and/or containing a large amount of sugar alcohol during the screening period. 5. Who have allergic to food. 6. Who have serious diseases requiring an urgent treatment, or who accept severe complication. 7. Who has a medical history of diseases or surgery affecting digestion, absorption and bowel movement (except for appendicectomy). 8. Who are judged unsuitable for this study based on subject questionnaire. 9. Who is pregnant or willing to be pregnant or brest-feeding during this study. 10. Who has a current or history of drug dependence and/or alcoholism. 11. Who are participated in another clinical trial that intake/apply any of food, drug, and cosmetics, or willing to be that. 12. Who are judged unsuitable for this study by test responsibility doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Defecation frequency and days of defecation and amount of defecation will be measured. The change will be compared with placebo-controlled groups. | — |
Countries
Japan
Contacts
KSO Corporation Sales Department