Male/female adults
Conditions
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Subjects who are age of at least 18 years of age and less than 65 years. 2.Subjects who received an enough explanation of the test objectives and detail, who have consent ability, who are willing to participate with well understandings and who have signed the informed consent document.
Exclusion criteria
Exclusion criteria: 1.Subjects who have a history of serious illness. 2.Subjects who are under treatment with medication for chronic diseases. 3.Subjects who are unable to discontinue foods or supplements containing lactic acid bacteria, bifidobacteria, oligosaccharides, etc. during the study period. 4.Subjects who have digestive tract diseases that affect digestion and absorption, and have had a history of gastrointestinal surgery (excluding appendicitis). 5.Subjects who are under treatment for or have a history of drug addiction and/or alcoholism. 6.Subjects who are planning to participate in other clinical studies. 7.Subjects who are under treatment for or have a history of drug allergies or severe food allergies. 8.Subjects who are pregnant or under lactation, or who is expected to be pregnant during the study period. 9.Heavy alcohol drinkers (average of more than 20g of alcohol/day in terms of pure alcohol). 10.Excessive smokers (21 or more cigarettes per day). 11.Subjects who have had more than 400 mL of blood drawn within 12 weeks prior to the start of intake, or more than 200 mL of blood drawn during the previous observation period. 12.Subject who were tested positive for infectious diseases at the time of screening test. 13.Subjects who have been deemed unsuitable as study participants by the principal investigator or sub-investigator based on their background, physical examination, blood pressure, pulse rate, and clinical test results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Questionnaire Physical measurement (height, weight (BMI)) Blood pressure and pulse rate Hematology Biochemistry Urinalysis Self and other symptoms Adverse events and side effects | — |
Countries
Japan
Contacts
Public ContactEiji Yoshikawa
KSO Corporation Clinical Trial Management department
Outcome results
None listed