Effects of consumption of the test beverage on the defecation in healthy Japanese subjects

UMIN ID: UMIN000047765

Registered date:16/05/2022

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Healthy Japanese subjects
• Date of first enrollment: 2022/04/28
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Duration: Two weeks Test beverage: Beverage containing lactic acid bacteria and yeast Administration: Drink one pack each before breakfast and dinner (two packs per day) *Daily dose should be taken within the day. If you forget to take the test beverage, take it as soon as you remember within the day.
Duration: Two weeks Test beverage: Placebo beverage Administration: Drink one pack each before breakfast and dinner (two packs per day) *Daily dose should be taken within the day. If you forget to take the test beverage, take it as soon as you remember within the day.

Outcome(s)

• Primary Outcome: 1. Defecation frequency at the 2nd week after consumption of test beverage
• Secondary Outcome: 1. Defecation frequency at the 1st week after consumption of test beverage 2. Numbers of defecation days and amount of defecation at the 1st and 2nd week after consumption of test beverage 3. Stool shape, stool smell, and exhilarating feeling of defecation at the 1st and 2nd week after consumption of test beverage 4. The score of The Japanese Version of the Constipation Assessment Scale (CAS) at two weeks after consumption (2w) 5. Each item of CAS at 2w

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1. Subjects who have drinkning habit on an empty stomach or who sometimes have diarrheal due to drinking 2. Subjects who are diarrheal tendency 3. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 4. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 5. Subjects who currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 6. Subjects who take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily use 7. Subjects who currently taking medications (including herbal medicines) and supplements 8. Subjects who are allergic to medicines and/or the test beverage related products 9. Subjects who are pregnant, lactation, or planning to become pregnant 10. Subjects who suffer from COVID-19 11. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 12. Subjects who are judged as ineligible to participate in the study by the physician

Related Information

• Primary Sponsor: ORTHOMEDICO Inc.
• Secondary Sponsor: Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
• Source(s) of Monetary Support: maikon no kohara Corporation.