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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024555
Receipt No. R000028233
Scientific Title Novel approach to coronary artery disease through the gut microbiota and its metabolite
Date of disclosure of the study information 2017/01/01
Last modified on 2017/02/09

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Basic information
Public title Novel approach to coronary artery disease through the gut microbiota and its metabolite
Acronym Prevention and treatment of coronary artery disease through the gut
Scientific Title Novel approach to coronary artery disease through the gut microbiota and its metabolite
Scientific Title:Acronym Prevention and treatment of coronary artery disease through the gut
Region
Japan

Condition
Condition coronary artery disease
Classification by specialty
Cardiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the characterization of gut microbial metabolites in the patients with coronary artery disease.
And to clarify prebiotics and probiotics which can prevent or treat coronary artery disease.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To elucidate the gut microbiota and its metabolites in feces after co-culture with prebioticas or probiotics in Kobe University Human Intestinal Model (KUHIM).
The difference of the gut microbiota and its metabolites in feces after co-culture with prebioticas or probiotics in KUHIM between coronary artery disease patients and control patients.
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 Coronary artery disease group
=patients diagnosed as coronary artery disease

Control group
=patients who have coronary risk factors such as hypertension, dyslipidemia, and/or diabetes, but who do not have coronary artery disease.
Key exclusion criteria 1) serum creatinine of greater than or equal to 3.0 mg/dL
2) patients with NYHA of greater than or equal to 3
3) patients with malignancy
4) patients with autoimmune disease or chronic inflammatory state
5) patients with inflammatory bowel diseases or intestinal surgery
6) BMI of more than 30kg/m2 or less than 15kg/m2
7) patients with low left ventricular ejection fraction (LVEF < 45%)
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ken-ichi Hirata
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 6500017, Japan
TEL 078-382-5111
Email hiratak@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 6500017, Japan
TEL 078-382-5111
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 Kobe university graduated school of science, technology, and innovation
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 01 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 Enrolling by invitation
Date of protocol fixation
2016 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 02 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 We co-culture feces of coronary artery disease patietns with various prebiotics/probiotics in Kobe University Human Intestinal Model. The purpose of this study is to identify the prebiotics/probiotics which can lead gut microbiota and its metabolites considered to be cardiovascular protective.

Management information
Registered date
2016 Year 10 Month 25 Day
Last modified on
2017 Year 02 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028233

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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