Subjects with a tendency for constipation
Conditions
Interventions
Food containing lactic acid bacteria (2 weeks intake) - washout period (2 weeks) - placebo (not containing lactic acid bacteria) (2 weeks intake)
Placebo (not containing lactic acid bacteria) (2 weeks
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Males and females from 20 to 64 years of age (2) Subjects with a tendency for constipation at three to five times of defecation per week at the point of screening examination(2 weeks) (3) Subjects giving written informed consent
Exclusion criteria
Exclusion criteria: (1) Individuals taking antiflatulents and/or laxatives (including purgative drug) in common use (2) Individuals taking health foods in common 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 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 and food with function claim, which influence intestinal regulation during the study period (5) Individuals presenting known food allergy (6) Individuals taking large amounts of alcohol on a daily basis (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 who are judged to be unsuitable as a subject from an answer of a subjective background questionnaire (10) Individuals who are pregnant or breast-feeding, or have the will of pregnancy during the study period (11) Individuals who are under treatment or have a history of drug/alcohol dependence (12) Individuals who participate in other clinical studies or who are in willing to participate to these studies using foods, drugs and/or cosmetics (13) Individuals who are judged as unsuitable for the study by the investigator for the other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Lactobacillus genus in feces, number of Bifidobacterium genus in feces, acetic acid content in feces | — |
Secondary
| Measure | Time frame |
|---|---|
| Organic acids content in feces, analysis of gut microbiota, diversity of gut microbiota, metagenomic analysis of functional profile of gut microbiota community, ammonia content in feces, decay product content in feces, pH and water content in feces, questionnaire(Defecation days, defecation frequency, fecal amount fecal shape, fecal color, fecal odor, feeling after defecation) | — |
Countries
Japan
Contacts
Public ContactEiji Yoshikawa
KSO Corporation Sales department
Outcome results
None listed