A clinical study for evaluating the efficacy of "Zendamakin-no-chikara" containing Lactcoccus lactis subsp. Cremoris FC on fanction of intestinal bacterial flora regulation. -Randomised double-blind placebo-controlled trial
- Conditions
- Healthy adult
- Registration Number
- JPRN-UMIN000024013
- Lead Sponsor
- KSO Corporation
- Brief Summary
The continuous ingestion of L. lactis subsp. cremoris FC caused changes in intestinal microflora, improving defecation status and fecal characteristics in healthy subjects prone to constipation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Not provided
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.