Healthy adults
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adults 2. Persons who defecate two to five times per week
Exclusion criteria
Exclusion criteria: 1. Subjects who have at least one previous medical history of malignant tumor, heart failure or myocardial infarction 2. Subjects who being treated or have medical history for at least one of following diseases: cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases 3. Subjects who currently take Food for Specified Health Uses, Foods with Functional Claims, yogurt, and/or lactic fermenting beverage and/or food 4. Subjects who currently take medicines (include herbal medicines) and/or supplements 5. Subjects who are allergic to medicines or relate to the test food of this trial 6. Subjects who are pregnant, lactating, or planning to get pregnant during the trial period 7. Subjects who have enrolled into other clinical trials within the last 3 months before the date signed written informed consent in this trial 8. Subjects are judged as unsuitable for participating in this trial by physician for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Enterobacterial flora (Bifidobacterium, Lactobacillales, Bacteroides, Prevotella, Clostridium cluster IV, Clostridium cluster IX, Clostridium cluster XI, Clostridium cluster XVIII, and Clostridium subcluster XIVa) *1 Perform the test at 0 week and at 1 and 2 weeks after ingestion | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The Japanese version of Constipation Assessment Scale MT version (CAS-MT) *1 Perform the test at 0 week and at 1 and 2 weeks after the ingestion 2. Stool form scale *2 Perform the test at 0 week and at 1 and 2 weeks after the ingestion 3. Bowel movement diary *3 Record it when having bowel movements | — |
Countries
Japan
Contacts
ORTHOMEDICO Inc. R&D Department