Healthy Japanese adults
Conditions
Interventions
Duration: 12 weeks Test materials: Tablets containing Bacillus subtilis Dose: 3 tablets per day Administration: Take 3 tablets after breakfast with water. Do not chew tablets. * Daily dose must be
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Medical Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adults 2. Subjects who are judged as eligible to participate in the study by the principal investigator 3. Among the subjects who passed 2., select the participants according to the following rules 20s: 2 or more male and female, 30s: 2 or more male and female, 40s: 4 or more male and female, 50s: 4 or more male and female, 60 or more to less than 80 years old: 6 or more male and female 4. Select the participants as equal as possible from subjects who have loose stool *1, constipated subjects *2, and subjects who have normal stool *3 *1 Subjects whose weekly average of bristol scale score is more than 5 *2 Subjects who defecate 2 to 4 times per week *3 Subjects whose weekly average of bristol scale score is less than 5 and defecate more than 4 times per week
Exclusion criteria
Exclusion criteria: 1. At least one previous medical history or under the treatment of malignant tumor, heart failure or myocardial infarction 2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, irritable bowel syndrome (IBS) or other chronic diseases 3. Subjects who use or take "Foods for Specified Health Uses" and "Foods with Functional Claims" in daily 4. Currently taking medicines (include herbal medicines) and supplements *Particularly taking warfarin 5. Subjects who are allergic to medicines and/or the test food related products *Particularly soybeans, natto allergy 6. Subjects who have lactose intolerance 7. Subjects who are pregnant, breast-feeding, and plan to become a pregnant 8. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial 9. Subjects who are judged as ineligible to participate in the study by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Body measuring / Physical examination 2. Urinalysis 3. Blood test 4. Questionnaire (the Likert scale) 5. Bowel movement diary *1-4 Perform the test at 0 week and at 4, 8, and 12 weeks after ingestion *5 Record when having the defecation from a week before screening test to a day before the final test | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed