A randomized double-blind placebo-controlled trial for improving the intestinal environment in huma
- Conditions
- Healthy adults
- Registration Number
- JPRN-UMIN000022760
- Lead Sponsor
- ORTHOMEDICO, Inc.
- Brief Summary
Hoshino T, Yamashita S, Suzuki N, Takara T. Effects of Food Containing Resistant Dextrin and Galactooligosaccharides on the Intestinal Environment in Healthy Japanese Adults. -A Randomized, Double-blind, Placebo-controlled, Parallel-group Trial-. Jpn Pharmacol Ther. 2018; 46(10): 1707-1722
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
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 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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