Unique ID issued by UMIN | UMIN000026554 |
---|---|
Receipt number | R000030287 |
Scientific Title | The effect of protease derived from Aspergillus oryzae on physiological function of healthy subject -randomized double-blind placebo control trial- |
Date of disclosure of the study information | 2017/04/01 |
Last modified on | 2019/03/17 07:58:29 |
The effect of protease derived from Aspergillus oryzae on physiological function of healthy subject -randomized double-blind placebo control trial-
The effect of protease derived from Aspergillus oryzae on physiological function of healthy subject -randomized double-blind placebo control trial-
The effect of protease derived from Aspergillus oryzae on physiological function of healthy subject -randomized double-blind placebo control trial-
The effect of protease derived from Aspergillus oryzae on physiological function of healthy subject -randomized double-blind placebo control trial-
Japan |
Healthy subject
Adult |
Others
NO
To investigate the safety and intestinal regulator function such as improvement of intestinal flora and bowel movement of protease derived from Aspergillus oryzae on human.
Safety,Efficacy
Exploratory
Explanatory
Not applicable
Analysis of intestinal flora in stool after 2-w
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)
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
NO
No need to know
3
Treatment
Other |
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
Intestinal flora analysis after 2-w
Active: PR-ASD 600mg
2-w repeated consumption
Dose of 1 cap after every meal
Intestinal flora analysis after 2-w
20 | years-old | <= |
80 | years-old | >= |
Male and Female
Healthy subject
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.
60
1st name | Makoto |
Middle name | |
Last name | Sasaki |
Aichi Medical University School of Medicine
Gastroenterology
4801195
1-1 Yazakokarimata, Nagakute
0561-62-3311
msasaki@aichi-med-u.ac.jp
1st name | Makoto |
Middle name | |
Last name | Sasaki |
Aichi Medical University School of Medicine
Gastroenterology
4801195
1-1 Yazakokarimata, Nagakute
0561-62-3311
msasaki@aichi-med-u.ac.jp
Aichi Medical University School of Medicine
Amano Enzyme Inc.
Profit organization
Amano Enzyme Inc.
Ethics review committee of Aichi Medical University School of Medicine
1-1 Yazakokarimata, Nagakute
0561-62-3311
syomu@aichi-med-u.ac.jp
NO
2017 | Year | 04 | Month | 01 | Day |
Unpublished
Completed
2017 | Year | 02 | Month | 09 | Day |
2017 | Year | 03 | Month | 17 | Day |
2017 | Year | 04 | Month | 01 | Day |
2017 | Year | 12 | Month | 31 | Day |
2017 | Year | 03 | Month | 14 | Day |
2019 | Year | 03 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030287
Research Plan | |
---|---|
Registered date | File name |
2019/03/17 | 研究計画書【第1版】.docx |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |