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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027975
Receipt No. R000032012
Scientific Title The interaction between gut microbiota and cardiac disease, metabolic syndrome
Date of disclosure of the study information 2017/09/01
Last modified on 2018/01/16

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Basic information
Public title The interaction between gut microbiota and cardiac disease, metabolic syndrome
Acronym Cardiac disease, metabolic syndrome and gut microbiota
Scientific Title The interaction between gut microbiota and cardiac disease, metabolic syndrome
Scientific Title:Acronym Cardiac disease, metabolic syndrome and gut microbiota
Region
Japan

Condition
Condition Cardiac disease (angina pectoris, valvular disease, heart failure, arrhythmia, pulmonary hypertension, and so on)
Metabolic syndrome(diabetes mellitus, hypertension, hyperuricemia, and so on)
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the characterization of gut microbiota and gut microbial metabolites mediated mechanisms of pathogenesis of cardiac disease.
Basic objectives2 Others
Basic objectives -Others To clarify prebiotics and probiotics which can prevent or treat cardiac disease.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change of gut microbiota in the patients with cardiac disease
Key secondary outcomes Gut microbial metabolites in the patients with cardiac disease.

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
80 years-old >
Gender Male and Female
Key inclusion criteria Patients with cardiac disease and metabolic syndrome who agree to this study.
Key exclusion criteria Patients who do not agree to this study and those who are not appropriate for t his study.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yamashita Tomoya
Organization Kobe University School of medicine
Division name Department of cardiology
Zip code
Address 7-5-2 Kusunoki-cho Chuo-ku Kobe City
TEL 078-382-5846
Email tomoya@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yamashita Tomoya
Organization Kobe University Hospital
Division name Department of cardiology
Zip code
Address 7-5-2 Kusunoki-cho Chuo-ku Kobe City
TEL 078-382-5846
Homepage URL
Email tomoya@med.kobe-u.ac.jp

Sponsor
Institute Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor National institutes of biomedical innovation, health and nutrition
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 06 Month 26 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information obeservational study

Management information
Registered date
2017 Year 06 Month 28 Day
Last modified on
2018 Year 01 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032012

Research Plan
Registered date File name
2017/12/28 170109_ICF1.0_20170703_.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name


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