Tokyo, Aug. 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058763) titled 'Evaluation of the effects of food intake on oral microbiota' on Aug. 12.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - No treatment

Primary Sponsor: Institute - Kyushu University

Condition: Condition - Healthy volunteers Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To investigate the effects of test substance intake for 4 weeks on the oral microbiota in a randomized controlled trial (RCT) compared to the control group. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Continuous intake of tablets containing test substance for 4 weeks Interventions/Control_2 - No intake of tablets containing test substance

Eligibility: Age-lower limit - 4 years-old = Gender - Male and Female Key inclusion criteria - 1)Healthy infants (4-6 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 Key exclusion criteria - 1) Subjects who consciously use products claiming to be effective, such as test substance. 2) Subjects who have been diagnosed with caries by screening tests 3) Subjects undergoing dental caries treatment 4) Subjects who have declared that they have an allergy to the research food 5) Guardians who are participating in the test of ingesting other foods or medicines, and those who are willing to participate 6) Subjects taking antibiotics or antibacterial agents, or who have taken them within 3 months of the screening test 7) Subjects with a history of congenital or circulatory diseases 8) Others who are judged by the investigator to be inappropriate as subjects Target Size - 100

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 07 Month 08 Day Date of IRB - 2025 Year 08 Month 08 Day Anticipated trial start date - 2025 Year 08 Month 08 Day Last follow-up date - 2025 Year 11 Month 29 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067138

Disclaimer: Curated by HT Syndication.