Tokyo, Aug. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062631) titled 'A study to evaluate the efficacy of tablets containing lactic acid bacteria in improving the oral environment' on Aug. 21.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Asahi Group Foods, Ltd.

Condition: Condition - N/A Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to evaluate the effects of the intake of test food on the oral environment. In addition, the effects of different intake levels will be explored. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Consumption of the test food (1 tablet a day) for 4 weeks (intake level 1). Interventions/Control_2 - Consumption of the test food (1 tablet a day) for 4 weeks (intake level 2).

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1) Males and females aged 20 years or older but under 65 years at the time of obtaining informed consent to participate in the study. 2) Individuals with mild to moderate gingivitis or periodontitis. 3) Individuals who have not undergone dental procedures, such as scaling or professional dental cleaning, that may affect the oral environment at the assessment sites within the past year. 4) Individuals in whom at least four of the six index teeth used for oral examinations can be assessed, or who have substitute teeth specified in the study protocol. 5) Individuals who are not currently receiving treatment for dental caries or periodontal disease and who have at least 20 teeth. 6) Individuals who have received sufficient explanation regarding the purpose and content of this study, possess the capacity to provide consent, voluntarily agree to participate after fully understanding the study, and can provide written informed consent to participate in this study. Key exclusion criteria - 1) Individuals judged at the screening examination to have dental caries classified as C3 or higher, or severe periodontal disease. 2) Individuals who have diabetes mellitus, chronic kidney disease, gastrointestinal disorders, pulmonary disease, malignant tumors, or other relevant diseases and are taking medication for these conditions. 3) Individuals with systemic diseases that make participation in the study difficult. 4) Individuals who are currently taking antibiotics or antimicrobial agents, or who have taken such agents within one month before the screening examination. 5) Individuals who are unable to discontinue, during the study period, the use or consumption of dental professional products or dentifrices that may affect the study results; foods containing lactic acid bacteria, bifidobacteria, or oligosaccharides; or supplements or health foods, including Foods for Specified Health Uses and Foods with Function Claims, that may affect oral hygiene. 6) Individuals who use products intended to prevent periodontal disease, such as interdental brushes or dental floss. 7) Individuals who are pregnant or lactating, or who intend to become pregnant during the study period. 8) Individuals who are currently participating in another study involving a drug or food, or who intend to participate in another such study. 9) Individuals whose stimulated saliva volume over 5 minutes is 3.0 mL or less, or who have been diagnosed with dry mouth. 10) Individuals whose stimulated salivary pH is 6.2 or lower. 11) Individuals with food allergies. 12) Individuals who wear removable dentures or have implants in the teeth designated for oral examination. 13) Individuals who are currently undergoing orthodontic treatment. 14) Smokers. 15) Individuals who plan to travel overseas for personal or business purposes during the study period. 16) Individuals deemed unsuitable for participation in this study by the principal investigator. Target Size - 45

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2026 Year 06 Month 03 Day Date of IRB - 2026 Year 06 Month 04 Day Anticipated trial start date - 2026 Year 07 Month 19 Day Last follow-up date - 2026 Year 09 Month 06 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071690

Disclaimer: Curated by HT Syndication.