The verification study for improving the intestinal environment: A randomized open-label parallel-group study
- Conditions
- Healthy Japanese adults
- Registration Number
- JPRN-UMIN000028606
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 14
Not provided
1. At least one previous medical history or under the treatment 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 or other chronic diseases 3. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", food/beverage including lactic acid bacteria, or other functional food/beverage in daily 4. Currently taking medicines (include herbal medicines) and supplements 5. Subjects who are allergic to medicines and/or the test food related products 6. Subjects who are allergic to latex 7. Subjects who are pregnant, breast-feeding, and plan to become a pregnant 8. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial 9. Subjects who are judged as ineligible to participate in the study by the principal investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. The Japanese version of Constipation Assessment Scale MT version (CAS-MT) * Assess at screening and examination before consuming, and at 1, 2, 3, and 4 weeks after consuming
- Secondary Outcome Measures
Name Time Method 1. Bacterial flora analysis (Terminal Restriction Fragment Length Polymorphism; T-RFLP) 2. Subjective symptoms a. Bowel movement diary b. Bristol scale *1 Assess at 0 and 4 weeks after consuming *2 Record the diary from a week before consuming to the day before 4 weeks after consuming