Healthy adults
Conditions
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy Japanese men and women aged 20 and over but under 65, who have bowel movements 3 to 5 times per week. 2) Subjects whose Bifidobacterium count in the feces collected at screening was low and the proportion relative to the total bacterial count was also low. 3) Subjects who usually eat 3 meals regularly. 4) Subjects who have received a sufficient explanation of the purpose and content of the study, have the ability to consent, voluntarily applied to participate in the study after a good understanding, and have agreed to participate in the study in writing.
Exclusion criteria
Exclusion criteria: Subjects who 1)are suffering from or have a history of serious liver disease, kidney disease, gastrointestinal disease, heart disease, respiratory disease, endocrine disease, thyroid disease, adrenal gland disease, or other metabolic disease. 2)regularly use laxatives and probiotics. 3)cannot stop consuming health foods believed to improve constipation during the study period. 4)cannot stop consuming probiotic-containing foods such as lactic acid bacteria, bifidobacteria, and Bacillus natto, prohibited foods fortified with oligosaccharides and dietary fiber, specified health foods that are thought to improve constipation, foods with functional claims, and foods with high sugar alcohol concentrations during the study period. 5)have been regularly consuming foods containing lactobacilli, bifidobacteria, and oligosaccharides for the purpose of alleviating constipation. 6)have taken antibiotics within the past 2 weeks during the screening test or control food intake period. 7)have a history of digestive diseases or surgical procedures affecting digestion and defecation. 8)been diagnosed with Irritable Bowel Syndrome or Inflammatory Bowel Disease. 9)have self-reported allergies to ingredients in the study food materials. 10)cannot stop drinking from 2 days before each measurement. 11)have excessive alcohol intake more than approximately 20 g / day of pure alcohol equivalent or habit of drinking more than 5 days a week. 12)are shiftworker or midnight-shift worker. 13)are pregnant or wish to become pregnant during the study period or are breastfeeding. 14)have donated blood or blood components exceeding 200 mL within one month prior to the consent date or 400 mL within three months prior to the consent date. 15)plan to participate in other clinical study during study periods or had participated in other clinical study within the last 1 month. 16)are judged by the principal investigator to be inappropriate as study subjects for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Defecation frequency | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Frequency of bowel movements, stool volume, stool consistency, color, odor, and post-defecation sensation. (2) Metagenomic analysis using next-generation sequencing. 3) Ammonia Concentration in Stool. 4) Fecal Putrefaction Products (Indole, p-Cresol, Skatole, Phenol, 4-Ethylphenol). | — |
Countries
Japan
Contacts
Public ContactYoshika Komori
KSO Corporation Clinical Trial Management department
Outcome results
None listed