Healthy adults
Conditions
Interventions
Duration: 2 weeks Test material: "
Onaka Kaichou Sengen"
Dose: Take 3 sticks a day Administration: Once a day during a meal
Duration: 2 weeks Test material: Placebo Dose: Take 3 sticks a day Administration: Once a day during a meal
Sponsors
ORTHOMEDICO, Inc.
Seishin-kai Medical Association Inc, Takara Medical Clinic.
Eligibility
Sex/Gender
All
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 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 medicines (include herbal medicines) 4. Subjects who currently take Food for Specified Health Uses, Foods with Functional Claims, yogurt, and/or lactic fermenting beverage 5. Subjects who are allergic to medicines or foods related to the test food of this trial 6. Subjects who currently take supplements or fortified foods 7. Subjects who are pregnant, lactating, or planning to get pregnant during the trial period 8. Subjects who have enrolled into other clinical trials within the last 3 months before agreeing to participate in this trial 9. 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, Clostridium subcluster XIVa, and others) *1 Perform the test at 0 week and at 1 and 2 weeks after the 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 Recording about the defecation every day | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO, Inc. R&D Department
Outcome results
None listed