Tokyo, Aug. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058663) titled 'Investigation on diseases, constitutions, lifestyles, and gut microbiota associated with oral microbiota' on Aug. 1.
Study Type:
Observational
Primary Sponsor:
Institute - Cykinso, Inc.
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the relationship between oral bacteria and diseases, constitution, lifestyle, and gut microbiota
Basic objectives2 - Others
Eligibility:
Age-lower limit - 40
years-old
Gender - Male and Female
Key inclusion criteria - 1. Healthy Japanese men and women aged 40 to 70 at the time of obtaining consent.
2. Subjects who have 20 or more of their own teeth (not including implants).
3. Subjects who receive a sufficient briefing of the objective and content of the present study, fully understand and agree to voluntarily participate in the study.
Key exclusion criteria - 1. Subjects who have used antibiotics within the past two months
2. Subject who undergoing orthodontic treatment
3. Subject who currently have a smoking habit (including e-cigarettes)
4. Female subjects who are pregnant or lactating, or intending to become pregnant during the study
5. Subjects who took part in another study within 3 months prior to the start of the present study or who is currently taking part in another study
6. Subjects deemed unsuitable by the principal investigator
Target Size - 100
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 07 Month 22 Day
Date of IRB - 2025 Year 07 Month 24 Day
Anticipated trial start date - 2025 Year 08 Month 01 Day
Last follow-up date - 2025 Year 10 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067079
Disclaimer: Curated by HT Syndication.
