people tend to be constipated
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Who meet the following conditions will be required. Whose defecation frequency is no fewer than 3, nor more than 5, and meal times are three a day usually. (Who gave the informed consents in writing after receiving enough explanation of the purpose and detail of the study, understanding the study well, and deciding to attend the study with their own will.)
Exclusion criteria
Exclusion criteria: Who meet any of the following conditions will be excluded. 1,Who regularly use intestinal drug and laxatives(including strong laxatives). 2,Who use medicine such as antibiotics that affect digestion and absorption. 3,Who can not stop intake the health food to relieve constipation (including Food for Specified Health Uses (FOSHU)) during the screening period. 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 relieve constipation (including Food for Specified Health Uses (FOSHU)) and/or containing a large amount of sugar alcohol during the screening period. 5, Who habitually consume higher amount of alchole (more than 360mL in terms of Japanese Sake per day). 6, Who can not stop intake food containing Euglena gracilis. 7, Who has chronic malady of digestive organ authorities. 8,Who have allergic to food. 9, Who has a medical history of diseases or surgery affecting digestion, absorption and bowel movement (except for appendicectomy). 10,Who have serious diseases requiring an urgent treatment, or who accept severe complication. 11, Who is pregnant or willing to be pregnant or breast-feeding during this study. 12, Who are participated in another clinical trial that intake/apply any of food, drug, and cosmetics, or willing to be that. 13,Who are judged unsuitable for this study by test responsibility doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Defecation frequency and days of defecation frequency and amount of defecation will be measured. The changes will be compared with placebo-controlled groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Bristol Stool Form Scale, stool color and smell, feeling after defecation will be measured. The changes will be compared with placebo-controlled groups. | — |
Countries
Japan
Contacts
KSO Corporation Sales department