Clinical Trial: Examination of the effect of food containing Lactobacillus salivarius WB21 on oral Candida species (Randomized, placebo-controlled, double-blind, parallel-group comparative study) (Japan)

Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058770) titled 'Examination of the effect of food containing WB21 on oral Candida species (Randomized, placebo-controlled, double-blind, parallel-group comparative study)' on Oct. 1.

Study Type: Interventional

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

Primary Sponsor: Institute - Fukuoka Dental College

Condition: Condition - oral candidiasis Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To prevent oral candidiasis, a randomized controlled trial will be conducted to clarify whether the continuous intake of food containing Lactobacillus salivarius WB21 (WB21), a lactic acid bacterium that has been confirmed to inhibit the growth of Candida albicans in in vitro studies, inhibits the growth of Candida in the oral cavity of elderly people who harbor Candida in their mouths, and thus prevents the onset of oral candidiasis. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Study participants will be asked to take "Avambees Oral Tablets" (Wakamoto Pharmaceutical Co., Ltd.), a food containing Lactobacillus salivarius WB21, three times a day for two weeks. Interventions/Control_2 - Study participants will take placebo tablets (Wakamoto Pharmaceutical Co., Ltd.) containing no Lactobacillus salivarius WB21 three times a day for two weeks.

Eligibility: Age-lower limit - 65 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Residents of a certain nursing home in Fukuoka City who has been found to have Candida in his or her oral cavity Key exclusion criteria - Those who are already using food containing WB21 / Those taking antibiotics / Those with a history of milk allergy or food allergy to food ingredients / Those who the researcher judges to be inappropriate as study participants Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 07 Month 15 Day Date of IRB - 2025 Year 08 Month 01 Day Anticipated trial start date - 2025 Year 10 Month 01 Day Last follow-up date - 2026 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067196

Disclaimer: Curated by HT Syndication.