Healthy volunteers
Conditions
Interventions
Powder food containing FK-23 (0.25 g)
Powder food containing FK-23 (0.075 g)
Powder food containing FK-23 (0.025 g)
Powder food not containing FK-23 (placebo)
Sponsors
Soiken Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Healthy subject within 20-65 years of age, both genders, with constipation tendency (with defecation frequency from 3 to 5 times per week) 2)Subject having a briefing of the content of the present study, fully understanding and agreeing to its objective and being able to personally sign a written informed consent
Exclusion criteria
Exclusion criteria: 1)Subject receiving treatment for gastrointestinal diseases 2)Subject having a medical history with organic constipation or irritable bowel syndrome 3)Subject taken medicines for intestinal disorder or laxatives 4)Subject taking medicine, quasi-drugs, food for specified health uses or foods with functional claims having the effects for intestinal functions 5)Subject having serious liver diseases, cardiovascular, respiratory, endocrine or metabolic disorders, or having a medical history with them 6)Subject have a medical history with test food-ralated allergy 7)Female subject who is pregnant or lactating, or intending to become pregnant during the study 8)Subject who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study 9)Subject deemed unsuitable by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Defecation frequency | — |
Secondary
| Measure | Time frame |
|---|---|
| Population of bifidobacterium to total bacteria, feeling after defecation, smell of feces, defecation days, fecal condition | — |
Countries
Japan
Contacts
Public ContactTomohiro Sugino
Soiken Inc. R&D Division
Outcome results
None listed