Tokyo, Aug. 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062348) titled 'Safety evaluation of long-term intake of food containing bifidobacterium in healthy adults' on Aug. 25.

Study Type: Interventional

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

Primary Sponsor: Institute - EP Mediate Co., Ltd.

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

Objective: Narrative objectives1 - To evaluate the safety of consuming a food containing bifidobacterium at the recommended daily intake for 12 consecutive weeks. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - Intake of food containing bifidobacterium at the recommended daily intake for 12 weeks

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - (1) Healthy male and female participants aged >=18 and <65 years. (2) Participants who, after fully understanding the purpose and content of the study, voluntarily consent to participate in the study of their own free will. Key exclusion criteria - (1) Participants who regularly consume foods containing high levels of the study-related component. (2) Participants who have previously shown abnormalities in clinical laboratory values or cardiopulmonary function and are judged by the principal investigator to be unsuitable for participation in the study. (3) Participants who are at risk of developing allergic reactions related to the study. (4) Participants who have diseases requiring continuous medication, are currently undergoing treatment (excluding dry eye and dental caries treatment), or have a history of serious diseases requiring pharmacological treatment. (5) Participants whose pre-intake clinical laboratory values or measurement results show markedly abnormal values outside the reference range. (6) Participants with irregular lifestyles, such as shift workers or those engaged in night work. (7) Participants who have participated in other clinical studies, clinical trials, or human studies within one month prior to the start of this study. (8) Participants who are pregnant, or planning to become pregnant or breastfeed during the study period. (9) Participants who are judged to be unsuitable as study participants based on responses to the lifestyle questionnaire. (10) Participants who are otherwise judged by the principal investigator to be unsuitable for participation in the study. Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 09 Day Date of IRB - 2026 Year 07 Month 09 Day Anticipated trial start date - 2026 Year 08 Month 26 Day Last follow-up date - 2026 Year 12 Month 23 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071355

Disclaimer: Curated by HT Syndication.