Tokyo, Aug. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058719) titled 'Effect of Different Intake Frequencies of Lactobacillus pentosus Strain B240 on Mucosal Immune Function' on Aug. 15.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Non-randomized Blinding - Single blind -participants are blinded Control - Placebo

Primary Sponsor: Institute - Waseda University

Condition: Condition - Not applicable Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to examine changes in salivary immunoglobulin A (SIgA) levels and subjective health status when varying the intake frequency of Lactobacillus B240, in order to determine whether reducing the frequency of intake can still produce beneficial effects. By doing so, the study seeks to clarify the optimal intake method for athletes, thereby reducing both the financial burden and the burden of intake on the athletes. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Intake of one Lactobacillus pentosus strain B240 tablet per day (containing two times ten to the power of nine CFU of Lactobacillus B240) for 28 consecutive days. Interventions/Control_2 - Intake of one Lactobacillus pentosus strain B240 tablet (containing two times ten to the power of nine CFU of Lactobacillus B240) three days per week, and placebo tablets on the remaining four days, for 28 consecutive days.

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - Healthy male and female adults aged 18 to 30 years who agree to participate in this study and comply with the study protocol. Key exclusion criteria - Members of university athletic clubs. Individuals undergoing continuous medical treatment for any disease. Individuals who will receive vaccinations during the study period. Individuals for whom the principal investigator, who is a physician, deems it inappropriate to perform the exercise stress test. Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 07 Month 31 Day Anticipated trial start date - 2025 Year 09 Month 01 Day Last follow-up date - 2025 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067109

Disclaimer: Curated by HT Syndication.