Tokyo, April 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061167) titled 'Safety Evaluation of Long-term Intake of a Probiotic food: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study' on April 6.

Study Type: Interventional

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

Primary Sponsor: Institute - IMEQRD Co. Ltd.

Condition: Condition - Healthy adults Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To assess the safety of 12-week intake of a probiotic food in healthy adults Basic objectives2 - Safety

Intervention: Interventions/Control_1 - Participants will take one sachet of the test food daily with water for 12 weeks. Interventions/Control_2 - Participants will take one sachet of the placebo food daily with water for 12 weeks.

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - 1. Aged 18 to under 65 at consent. 2. Able to enter study diary via smartphone or PC. 3. Fully informed of the study purpose and research content, able to consent, and voluntarily agreed in writing to participate. Key exclusion criteria - 1. History or presence of serious diseases: malignancy, respiratory, hepatic, renal, cardiac, pulmonary, gastrointestinal (including history of surgery affecting digestion/absorption), hematologic, endocrine, metabolic disorders, drug/alcohol dependence, psychiatric disorders. 2. Currently receiving treatment for any disease with medication or Kampo (as-needed drugs excluded). 3. BMI >=30.0 kg/m^2. 4. History or presence of drug or food allergies. 5. Severe anemia. 6. History of adverse reactions to blood sampling, vasovagal response, or difficulty with blood draws. 7. Pregnant, planning pregnancy during the study, or breastfeeding. 8. Heavy smokers (>=21 cigarettes/day). 9. Average daily alcohol intake >40 g (pure alcohol). 10. Unable to discontinue over-the-counter drugs, quasi-drugs, foods with health claims, or supplements during the study. 11. Scheduled for endoscopy, barium study, H. pylori eradication, or tooth extraction during the study. 12. Scheduled for vaccination during the study. 13. Women who donated >=400 mL blood within 16 weeks, men within 12 weeks, or anyone who donated >=200 mL within 4 weeks prior to consent. 14. Night shift/rotating workers, manual laborers, or those with irregular lifestyles, or likely to change lifestyle during the study. 15. Receiving physician-supervised exercise, dietary, or health guidance. 16. Participating in other studies involving food, drugs, cosmetics, or had participated in another clinical study within 4 weeks before consent. 17. Deemed unsuitable by the principal investigator based on background, physical findings, interview, vital signs, or lab results. Target Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 02 Month 25 Day Date of IRB - 2026 Year 03 Month 09 Day Anticipated trial start date - 2026 Year 04 Month 07 Day Last follow-up date - 2026 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069898

Disclaimer: Curated by HT Syndication.