UMIN ID: UMIN000051982
Registered date:27/08/2023
Evaluation of the effects of food intake on oral microbiota.
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Healthy volunteers |
| Date of first enrollment | 2023/08/27 |
| Target sample size | 30 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Continuous intake of tablets containing test substance, 3.0 g/day for 4 weeks |
Outcome(s)
| Primary Outcome | Oral microbiota |
|---|---|
| Secondary Outcome | Dental caries experience, oral hygiene status (dental plaque, tongue coating), snacking habits |
Key inclusion & exclusion criteria
| Age minimum | 4years-old |
|---|---|
| Age maximum | 5years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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 |
Related Information
| Primary Sponsor | KSO Corporation |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | LOTTE Co., Ltd. |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Eiji Yoshikawa |
| Address | Shibaura Omodaka Building 7F, 1-9-7 Shibaura, Minato-ku, Tokyo Japan 105-0023 |
| Telephone | 03-3452-7733 |
| eigyou27@kso.co.jp | |
| Affiliation | KSO Corporation Clinical Trial Management department |
| scientific contact | |
| Name | Eiji Yoshikawa |
| Address | Shibaura Omodaka Building 7F, 1-9-7 Shibaura, Minato-ku, Tokyo Japan |
| Telephone | 03-3452-7733 |
| eigyou27@kso.co.jp | |
| Affiliation | KSO Corporation Clinical Trial Management department |