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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028208
Receipt No. R000032287
Scientific Title Isolation of bacterial strains from human feces and its therapeutic applications
Date of disclosure of the study information 2017/09/01
Last modified on 2017/12/20

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Basic information
Public title Isolation of bacterial strains from human feces and its therapeutic applications
Acronym Isolation of bacterial strains from human feces
Scientific Title Isolation of bacterial strains from human feces and its therapeutic applications
Scientific Title:Acronym Isolation of bacterial strains from human feces
Region
Japan

Condition
Condition cardiovascular disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Isolation of bacterial strains from feces of human with or without cardiovascular disease.
Basic objectives2 Others
Basic objectives -Others none
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Confirm whether we successfully isolate the bacterial strains using polymerase chain reaction.
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
100 years-old >
Gender Male and Female
Key inclusion criteria 1. healthy volunteers
2. patients with risk factor of cardiovascular disease
3. patients with cardiovascular disease
Key exclusion criteria none
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoya Yamashita
Organization Kobe University Graduate School of Medicine
Division name Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL 078-382-5846
Email tomoya@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoya Yamashita
Organization Kobe University Graduate School of Medicine
Division name Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL 078-382-5846
Homepage URL
Email tomoya@med.kobe-u.ac.jp

Sponsor
Institute Kobe university
Institute
Department

Funding Source
Organization Kobe university
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor NITTO PHARMACEUTICAL INDUSTRIES
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
2017 Year 09 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
2017 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 09 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 In the future, we use the isolated bacterial strains for reserch.

Management information
Registered date
2017 Year 07 Month 13 Day
Last modified on
2017 Year 12 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032287

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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