Healthy volunteers
Conditions
Interventions
Continuous intake of tablets containing test substance, 3.0 g/day for 4 weeks
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Healthy infants at screening test (4-5 years old) 2)Guardians receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent
Exclusion criteria
Exclusion criteria: 1)Subjects who consciously use products claiming to be effective, such as test substance. 2)Subjects who regularly use toothpaste claiming that it contains test substance 3)Subjects who have been diagnosed with caries by screening tests 4)Subjects undergoing dental caries treatment 5)Subjects who have declared that they have an allergy to the research food 6)Guardians who are participating in the test of ingesting other foods or medicines, and those who are willing to participate 7)Subjects taking antibiotics or antibacterial agents, or who have taken them within 3 months of the screening test 8)Others who are judged by the investigator to be inappropriate as subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oral microbiota | — |
Secondary
| Measure | Time frame |
|---|---|
| Dental caries experience, oral hygiene status (dental plaque, tongue coating), snacking habits | — |
Countries
Japan
Contacts
Public ContactEiji Yoshikawa
KSO Corporation Clinical Trial Management department
Outcome results
None listed