Tokyo, Aug. 19 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062600) titled 'Safety Study of Overdoses of Echizen-cheese starter lactic acid bacterium in Healthy Participants' on Aug. 19.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Fukui Prefectural University

Condition: Condition - none Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study will evaluate the safety of consuming excessive amounts of the test food in healthy adults. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - One treatment cycle will consist of 31 days. Anthropometric measurements, medical interviews, biochemical tests, and fecal sample collection will be conducted during the first 3 days. Participants will then consume capsules containing freeze-dried lactic acid bacteria powder (10^9 CFU per capsule) for the following 28 days, after which the same anthropometric measurements, medical interviews, biochemical tests, and fecal sample collection will be performed.

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - -Individuals who fully understand the nature and purpose of the study and provide written informed consent to participate. Key exclusion criteria - Individuals meeting any of the following criteria will be excluded from the study: -Individuals with an allergy to dairy products. -Individuals with gastrointestinal disorders, such as inflammatory bowel disease or irritable bowel syndrome. -Individuals with HIV infection or primary immunodeficiency; individuals currently receiving chemotherapy or radiotherapy for a malignant tumor; or individuals who are receiving continuous treatment with immunosuppressive drugs, including corticosteroids. -Individuals who have been diagnosed with valvular heart disease or who have a prosthetic heart valve. -Individuals with diabetes mellitus or elevated blood glucose levels. -Individuals who use or plan to use antibiotics, antifungal agents, or intestinal microbiota-modulating agents during the study period. -Individuals who follow any dietary restrictions for medical or religious reasons. -Individuals who are pregnant, breastfeeding, or planning to become pregnant. -Individuals deemed unsuitable for participation in the study by the principal investigator or the attending physician for any other reason. Target Size - 10

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 17 Day Date of IRB - 2026 Year 07 Month 10 Day Anticipated trial start date - 2026 Year 08 Month 17 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071490

Disclaimer: Curated by HT Syndication.