A randomized double-blind placebo-controlled trial for improving the intestinal environment in huma
- Conditions
- Healthy adults
- Registration Number
- JPRN-UMIN000023156
- Lead Sponsor
- ORTHOMEDICO, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Not provided
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 bifidobacteria and lactic acid bacteria beverage, bifidobacteria and lactic acid bacteria contains food 5. Subjects who are allergic to medicines or foods related to the test materials of this trial, particularly allergic to soy 6. Subjects who currently take supplements or nutrition enrichments 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 decided as unsuitable for participating in this trial by physician for other reasons
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Total intestinal bacterial count *1 Perform the test at 0 week and at 2 and 4 weeks after the ingestion
- Secondary Outcome Measures
Name Time Method 1. The Japanese version of Constipation Assessment Scale MT version (CAS-MT) *1 Answer CAS-MT at 0 week and at 2 and 4 weeks after the ingestion 2. Stool form scale *2 Answer stool form scale at 0 week and at 2 and 4 weeks after the ingestion 3. Bowel movement diary *3 Recording about the defecation every day 4. Analysis of peripheral blood {Diacron-Reactive Oxygen Metabolites (d-ROM), Bone Specific Alkaline Phosphatase (BAP)} *4 Perform the test at 0 week and 4 weeks after the ingestion 5. Stool analysis {Stool IgA, organic acids (succinic acid, lactic acid, formic acid, acetic acid, propionic acid, isobutyric acid, butyric acid, isovaleric acid, valeric acid), ammonia} *5 Analyze at 0 week and at 2 and 4 weeks after the ingestion (Stool IgA: Analyze at 0 week and 4 weeks after the ingestion)