Tokyo, July 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062185) titled 'Safety Evaluation of the High-Dose Intake of Probiotics: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Comparison Study' on July 17.

Study Type: Interventional

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

Primary Sponsor: Institute - TES Holdings Co., Ltd.

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

Objective: Narrative objectives1 - To evaluate the safety of consuming high dose of the test food in healthy adults. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - Intake of the test foods for 4 weeks. Interventions/Control_2 - Intake of the placebo foods for 4 weeks.

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - Participants aged 20 to 64 years old at the time of obtaining consent. Key exclusion criteria - 1) Participants currently taking medication for any disease. 2) Participants with serious diseases (such as malignant neoplasms, respiratory diseases, hepatic, renal, cardiac, pulmonary, or gastrointestinal diseases, hematological diseases, endocrine or metabolic diseases, drug dependence, alcohol dependence, or psychiatric disorders), or history of these diseases. 3) Participants with serious drugs or food allergies. 4) Participants with serious anemia. 5) Participants who are pregnant, breastfeeding, or planning pregnancy during the study period. 6) Participants with a BMI above 30 kg/m 2. 7) Participants with excessive alcoholic drinks (average pure alcohol intake > 40 g per day for men or > 20 g per day for women). 8) Participants with a habitual heavy smoking (average of >=21 cigarettes per day). 9) Participants who have donated >=400 mL blood within 16 weeks (women), >=400 mL blood within 12 weeks (men), or >=200 mL blood within 4 weeks prior to consent. 10) Participants in or intending to join other studies involving foods, drugs, cosmetics, or topical products, or who have joined other clinical studies within four weeks before consent. 11) Participants who regularly take medications that affect the intestinal environment (such as antibiotics, intestinal regulators, constipation medications, or laxatives). 12) Participants who cannot stop consuming foods for specified health uses, functional foods, nutrient function foods, supplements, or foods containing lactic acid bacteria, bifidobacteria, or oligosaccharides during the study period. 13) Participants who engage in night work or shift work, perform physical labor, or have irregular lifestyle habits, or who may change their lifestyle during the study period. 14) Participants judged ineligible for the study by the principal investigator. Target Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 06 Month 25 Day Date of IRB - 2026 Year 06 Month 25 Day Anticipated trial start date - 2026 Year 07 Month 28 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071135

Disclaimer: Curated by HT Syndication.