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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026554
Receipt No. 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

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Basic information
Public title The effect of protease derived from Aspergillus oryzae on physiological function of healthy subject -randomized double-blind placebo control trial-
Acronym The effect of protease derived from Aspergillus oryzae on physiological function of healthy subject -randomized double-blind placebo control trial-
Scientific Title The effect of protease derived from Aspergillus oryzae on physiological function of healthy subject -randomized double-blind placebo control trial-
Scientific Title:Acronym The effect of protease derived from Aspergillus oryzae on physiological function of healthy subject -randomized double-blind placebo control trial-
Region
Japan

Condition
Condition Healthy subject
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Analysis of intestinal flora in stool after 2-w
Key secondary outcomes 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)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment No need to know

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Control: placebo
2-w repeated consumption
Dose of 1 cap after every meal
Intestinal flora analysis after 2-w
Interventions/Control_2 Active: PR-ASD 150mg
2-w repeated consumption
Dose of 1 cap after every meal
Intestinal flora analysis after 2-w
Interventions/Control_3 Active: PR-ASD 600mg
2-w repeated consumption
Dose of 1 cap after every meal
Intestinal flora analysis after 2-w
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Healthy subject
Key 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.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Makoto
Middle name
Last name Sasaki
Organization Aichi Medical University School of Medicine
Division name Gastroenterology
Zip code 4801195
Address 1-1 Yazakokarimata, Nagakute
TEL 0561-62-3311
Email msasaki@aichi-med-u.ac.jp

Public contact
Name of contact person
1st name Makoto
Middle name
Last name Sasaki
Organization Aichi Medical University School of Medicine
Division name Gastroenterology
Zip code 4801195
Address 1-1 Yazakokarimata, Nagakute
TEL 0561-62-3311
Homepage URL
Email msasaki@aichi-med-u.ac.jp

Sponsor
Institute Aichi Medical University School of Medicine
Institute
Department

Funding Source
Organization Amano Enzyme Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Amano Enzyme Inc.
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics review committee of Aichi Medical University School of Medicine
Address 1-1 Yazakokarimata, Nagakute
Tel 0561-62-3311
Email syomu@aichi-med-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 02 Month 09 Day
Date of IRB
2017 Year 03 Month 17 Day
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 14 Day
Last modified on
2019 Year 03 Month 17 Day


Link to view the page
URL(English) https://upload.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


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