Healthy Japanese subjects
Conditions
Interventions
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 tak
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Subjects aged 20 or more 4. Healthy subjects 5. Subjects whose defecation frequency is three to five times per week 6. Subjects who are judged as eligible to participate in the study by the physician 7. Subjects whose defecation frequency is relatively few during a week before the screening (before consumption)
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Defecation frequency at the 2nd week after consumption of test beverage | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed