Healthy subject
Conditions
Interventions
Control: placebo 2-w repeated consumption Dose of 1 cap after every meal Intestinal flora analysis after 2-w
Active: PR-ASD 150mg 2-w repeated consumption Dose of 1 cap after every meal Intest
Sponsors
Aichi Medical University School of Medicine
Amano Enzyme Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy subject
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Analysis of intestinal flora in stool after 2-w | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Japan
Contacts
Public ContactMakoto Sasaki
Aichi Medical University School of Medicine Gastroenterology
Outcome results
None listed