Investigation of sample collection method for determination of Fusobacterium nucleatum in oral cavity
- Conditions
- ot applicable (Healthy adults)
- Registration Number
- JPRN-UMIN000043491
- Lead Sponsor
- Kyodo Milk Industry Co. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 6
Not provided
1. Subjects who have participated in other clinical trials requiring oral health care within 3 months prior to obtaining consent or are currently participating in other clinical trials. 2. Subjects with dentures (including implants) or undergoing orthodontic treatment. 3. Subjects who consumed antibiotics during last 3 months. 4. Subjects with serious or progressive diseases or conditions. 5. Subjects who are currently visiting a dentist or receiving treatment within 3 months prior to obtaining consent (any treatment related to teeth or gums). 6. Subjects who have been determined ineligible by principal investigator or study administrator. 7. Subjects who routinely consume medicines, health foods, supplements, food for specified health uses, or functional foods that affect the oral environment. 8. Subjects with a current or previous food or drug allergy. 9. Smoker 10. Subjects who have excessive drinking habits. 11. Subjects who are currently pregnant or breastfeeding, or who wish to become pregnant during the study period.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quantification of the number of Fusobacterium nucleatum and Fusobacterium spp. in oral specimens. Quantitative evaluation focusing on a specific strain.
- Secondary Outcome Measures
Name Time Method Detection and quantification of pathogenic genes of Fusobacterium nucleatum. 16S rRNA gene-based or shotgun metagenome analysis.