A randomized double-blind placebo-controlled trial for improving the intestinal environment in huma
- Conditions
- Healthy adults
- Registration Number
- JPRN-UMIN000016463
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
a) Persons who have previous medical history of malignant tumor or heart failure or myocardial infarction b) Patients being treated for at least one of following diseases atrial fibrillation, cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension and other chronic disease c) Persons who take medicines, herbal medicines, or supplement. d) Persons who are allergic to medicines, or products related to the test material of this trial e) Persons who habitually take foods that seem to be influential on intestinal environment, e.g., FOSHU, yogurt, and lactic fermenting beverage f) Persons who smoke g) Pregnant women, lactating women, or women who want to get pregnant during the trial period h) Persons who have been enrolled in the other clinical trials within last 3 months before the agreement for the participation to this trial i) Persons who are judged unsuitable to participate in this trial by physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Intestinal bacterial flora Bifidobacterium Lactobacillales Bacteroides Prevotella Clostridium cluster IV Clostridium subcluster XIVa Clostridium cluster XI Clostridium cluster XVIII Others
- Secondary Outcome Measures
Name Time Method Subjective symptom CAS-MT The faecal form scale