The effect of protease derived from Aspergillus oryzae on physiological function of healthy subject -randomized double-blind placebo control trial
Not Applicable
- Conditions
- Healthy subject
- Registration Number
- JPRN-UMIN000026554
- Lead Sponsor
- Aichi Medical University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
1. Bowel resection history 2. Heart disease, Liver disease, Kidney disease 3. Female during pregnancy (including who may be pregnant) or breast-feeding 4. Diarrhea tendency 5. Wheat allergy 6. Subject who is judged as ineligible for this study by responsible doctor or person in charge of this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Analysis of intestinal flora in stool after 2-w
- Secondary Outcome Measures
Name Time Method 1.Safety 2.Bowel movement 3.Score of QOL (interview sheet) 4.Clinical findings of abdominal symptom (interview sheet) 5.Blood test 6.Amount of components in stool(Ammonia, Mucin, IgA, Short chain fatty acid)