Healthy Japanese subjects
Conditions
Interventions
Duration: Four weeks Test food: Food containing S. boulardii Administration: Take two capsules per day after breakfast with water * Daily dose should be taken within the day. If you forget to ta
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Female 3. Subjects aged 30 or more and less than 50 4. Healthy subjects 5. Subjects who defecate three to five times per week 6. Subjects who are judged as eligible to participate in the study by the physician 7. Subjects who have relatively few defecation frequency during a week before Scr 8. Subjects whose the occupancy rate of Bifidobacterium or Lactobacillales at stool test of Scr is not 0%
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. 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 4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 5. Subjects who currently taking medications (including herbal medicines) and supplements 6. Subjects allergic to medications and/or the test-food-related products (especially yeast) 7. Subjects who are pregnant, lactation, or planning to become pregnant 8. 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 9. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The measured value of defecation frequency at period V* | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The amounts of changes from periods I* of defecation frequency in period V* 2. The measured values and amounts of changes from periods I* of defecation frequency in periods II to IV* 3. The measured values and amounts of changes from periods I* of defecation days and amount of defecation in periods II to V* 4. The percentages of shape and smell of stool and exhilarating feeling in periods II to V* 5. The measured values and amounts of changes from screening (before consumption; Scr) of CAS score of CAS-MT at four weeks after consumption (4w) 6. The measured values of scores for each item of CAS-MT at 4w 7. The measured values and amounts of changes from Scr of intestinal flora (Bifidobacterium, Lactobacillales, Bacteroides, Prevotella, Clostridium cluster IV, Clostridium cluster IX, Clostridium cluster XI, Clostridium subcluster XIVa, Clostridium cluster XVIII, Others) at 4w * Periods I~V are designed as below: period I, the seven days prior the Scr; period II, the seven days after initial consumption; period III, 8~14 days after consumption; period IV, 15~21 days after consumption; period V, 22 days after consumption to the day before 4w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed