Clinical Trial: Effects of test food consumption on the intestinal environment in healthy Japanese with bowel movement concerns: an open-label study (Japan)

Tokyo, Aug. 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058834) titled 'Effects of test food consumption on the intestinal environment in healthy Japanese with bowel movement concerns: an open-label study' on Aug. 19.

Study Type: Interventional

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

Primary Sponsor: Institute - NAGASE BeautyCare Co., Ltd.

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

Objective: Narrative objectives1 - To verify the effects of test food consumption on the intestinal environment in healthy Japanese. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Duration: Four weeks Test product: Food containing bifidobacteria Administration: Consume two packets per day after breakfast with water, without chewing.

*If you forget to consume the test product, do so as soon as you remember. Be sure to consume the daily amount within the same day and do not carry it over to the next day.

Eligibility: Age-lower limit - 18 years-old = 60 g/day a week

15. Individuals who are smokers or have not yet completed one year since quitting smoking

16. Individuals who have irregular eating habits, sleep habits, or exercise habits

17. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study

18. Individuals who are judged as ineligible to participate in this study by the physician Target Size - 18

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 08 Month 06 Day Date of IRB - 2025 Year 08 Month 06 Day Anticipated trial start date - 2025 Year 08 Month 19 Day Last follow-up date - 2025 Year 11 Month 23 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067274

Disclaimer: Curated by HT Syndication.