Tokyo, July 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062205) titled 'A verification study of the effects of consumption of the test food on the bowel movement' on July 10.

Study Type: Interventional

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

Primary Sponsor: Institute - ORTHOMEDICO Inc.

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

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

Intervention: Interventions/Control_1 - Duration: Four weeks Test product: Food containing Bifidobacterium longum KMH001 Administration: Take one capsule with water per day at any time during the day

*If a dose is missed, it should be consumed as soon as remembered. The daily dose should be consumed within the same day and should not be carried over to the following day. Interventions/Control_2 - Duration: Four weeks Test product: Placebo food Administration: Take one capsule with water per day at any time during the day

*If a dose is missed, it should be consumed as soon as remembered. The daily dose should be consumed within the same day and should not be carried over to the following day.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Japanese

2. Men or women

3. Adults

4. Healthy individuals

5. Individuals whose defecation frequency is three to five times per week Key exclusion criteria - 1. Individuals who are receiving treatment for or have a history of malignant tumors, heart failure, or myocardial infarction

2. Individuals who have an implanted pacemaker or implantable cardioverter defibrillator

3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. Individuals who consume Foods for Specified Health Uses or Foods with Functional Claims

5. Individuals who are taking or using medications (including herbal medicines) or supplements

6. Individuals who habitually drink more than 60 g/day of alcohol

7. Individuals who have surgical history of digestive organs

8. Individuals who are allergic to medications or foods related to the test product

9. Individuals who are pregnant, lactating, or planning pregnancy during this study

10. Individuals who are deemed unsuitable for participation in this study by the principal investigator Target Size - 30

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 06 Month 24 Day Date of IRB - 2026 Year 06 Month 24 Day Anticipated trial start date - 2026 Year 07 Month 10 Day Last follow-up date - 2026 Year 10 Month 12 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071186

Disclaimer: Curated by HT Syndication.