UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032644 |
|---|---|
| Receipt number | R000033800 |
| Scientific Title | The effect of Low Dose Aspirin towards Gut Microbita |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2019/01/17 22:27:38 |
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Basic information
Public title
The effect of Low Dose Aspirin towards Gut Microbita
Acronym
Aspirin and Gut Microbiota
Scientific Title
The effect of Low Dose Aspirin towards Gut Microbita
Scientific Title:Acronym
Aspirin and Gut Microbiota
Region
| Japan |
Condition
Condition
All conditions which requires beginning of aspirin use
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of low dose aspirin use on gut microbiota.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of the fecal microbiota using NGS
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
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
| 999 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients newly administrated to take low dose aspirin, and have agreed to enter this study
Key exclusion criteria
1 Use of NSAID, antibiotics, or probiotics within one month before entering the trial
2 Past history of intestinal inflammatory disease
3 Patients with intestinal stenosis
4 Patients with severe disorder of liver, kidney, neuro system, or mental
5 Possibility of pregnancy
6 Other situation which the chief investigator judge as inadequate
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuma Higurashi |
Organization
Yokohama City University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2640
takuma_h@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiichi Ashikari |
Organization
Yokohama City University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2640
Homepage URL
kei1.ashikari@gmail.com
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Biofermin co. ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 06 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 05 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
collect and evaluation of fecal samples
Management information
Registered date
| 2018 | Year | 05 | Month | 19 | Day |
Last modified on
| 2019 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033800
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| Registered date | File name |
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| Registered date | File name |
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