Healthy adults
Conditions
Interventions
Duration: 8 weeks Test material: Tablets containing Bacillus subtilis spores Dose: Take 3 tablets a day *2.2X109CFU/day Administration: Once a day
Duration: 8 weeks Test material: placebo Dose:
Sponsors
ORTHOMEDICO, Inc.
Seishin-kai Medical Association Inc, Takara Medical Clinic.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adults 2. Become aware of loose stools
Exclusion criteria
Exclusion criteria: 1. At least one previous medical history 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. Currently taking medicines (include herbal medicines), supplements, Food for Specified Health Uses, and/or Foods with Functional Claims *Particularly taking warfarin 4. Persons who eat natto more than 4 times per week 5. Persons who consume yogurt and/or beverages including lactic acid bacteria/bifidobacteria more than 4 times per week 6. Allergic to medicines or foods related to the test food of this trial. *Particularly soybeans, natto allergy 7. Pregnant, lactating, or planning to get pregnant during the trial period 8. Persons who have participated by 2015, "Bacillus subtilis, loose stools better effect validation test" 9. Enrolled into other clinical trials within the last 3 months before agreeing to participate in this trial 10. Judged unsuitable for participating in this trial by physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Bristol scale *1 Perform the test every day. 2. Water content in feces *2 Perform the test at 0 week and at 4 and 8 weeks after the ingestion 3. Gastrointestinal Symptom Rating Scale (GSRS) *3 Perform the test at 0 week and at 4 and 8 weeks after the ingestion | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Bowel in bacterial flora analysis *1 Perform the test at 0 week and at 4 and 8 weeks after the ingestion 2. Organic acids *2 Perform the test at 0 week and at 4 and 8 weeks after the ingestion 3. Decay products *3 Perform the test at 0 week and at 4 and 8 weeks after the ingestion 4. Short Form-8 (SF-8) *4 Perform the test at 0 week and 4 and 8 weeks after the ingestion | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO, Inc. R&D Department
Outcome results
None listed