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Investigation of sample collection method for determination of Fusobacterium nucleatum in oral cavity

Investigation of sample collection method for determination of Fusobacterium nucleatum in oral cavity - Investigation of sample collection method for determination of Fusobacterium nucleatum in oral cavity

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000043491
Enrollment
6
Registered
2021-05-01
Start date
2021-03-08
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Not applicable (Healthy adults)

Interventions

None listed

Sponsors

Kyodo Milk Industry Co. Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Subjects who show understanding of the study procedures and agreement with participating the study by written informed consent prior to the study.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Quantification of the number of Fusobacterium nucleatum and Fusobacterium spp. in oral specimens. Quantitative evaluation focusing on a specific strain.

Secondary

MeasureTime frame
Detection and quantification of pathogenic genes of Fusobacterium nucleatum. 16S rRNA gene-based or shotgun metagenome analysis.

Countries

Japan

Contacts

Public ContactNaomi Yuzawa

IMEQRD Co., Ltd Sales department

n-yuzawa@imeqrd.co.jp03-6704-5968

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026