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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032644
Receipt No. 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

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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
Email 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
Email kei1.ashikari@gmail.com

Sponsor
Institute Yokohama City University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033800

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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