Healthy adult
Conditions
Interventions
Capsule containing Lactococcus lactis subsp. Cremoris FC(100mg/serving) (2 weeks), washout(3 weeks), Placebo capsule(2 weeks)
Placebo capsule(2 weeks), washout(3 weeks), Capsule containing Lactococcus
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)(Healthy) subjects aged 30 to 59 years old (2)Subjects who there were few ratios for the number of Bifidobacterium in the feces at the time of screening examination and unevenness was small (4)Subjects giving written informed consent
Exclusion criteria
Exclusion criteria: (1)Individuals taking antiflatulents and/or laxatives(including purgative drugs) in common use (2)Individuals taking health foods in common use, including food for specified health use, which influence intestinal regulation at the point of screening examination (3)Individuals taking antibiotics and/or drugs which influence laxatives(including purgative drugs) in common use at the point of screening examination (4)Individuals daily consuming alcohol as equivalent amount of sake more than 360ml (5)Individuals who are not able to stop consumption of foods containing lactic acid bacteria, bifidobacteria, natto bacteria, oligosaccharides, dietary fibers, high amount of sugar alcohol and/or other health foods including food for specified health use, which influence intestinal regulation during the study period (6)Individuals presenting known food allergy (7)Individuals who are suffered from a disease which needs treatment urgently or individuals with severe complications (8)Individuals with a digestive organ disease or surgical history who has an influence on digestive absorption and defecation (9)Individuals infected with a disease to urgently need treatment, or having serious complications (10)Individuals who are pregnant or breast-feeding, or have the will of pregnancy during the study period (11)Individuals who participate in other clinical studies or who are in willing to participate to these studies using foods, drugs and/or cosmetics (12)Individuals who are judged as unsuitable for the study by the investigator for the other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Analysation of Enterobacterial flora (number of the total bacteria, Bifidobacterium genus, Lactobaccilus genus, Clostridium Perfringens) in feces by the real-time PCR method. Time of assessment: before and two weeks after intake of active/placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| Defecation frequency per day, Defecation frequency per week, Fecal amount. Time of assessment: after two-week intake of active/placebo, defecation frequency, defecation frequency and fecal amount are assessed on a weekly basis. Fecal shape, color and odor.Feeling after defecation. | — |
Countries
Japan
Contacts
Public ContactFumio Namba
FUJICCO Co., Ltd. R&D division
Outcome results
None listed