UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027975 |
|---|---|
| Receipt number | 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 | 2025/01/02 09:03:37 |
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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
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
tomoya@med.kobe-u.ac.jp
Sponsor or person
Institute
Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine
Institute
Department
Personal name
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
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
Main results already published
Date of protocol fixation
| 2017 | Year | 06 | Month | 26 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
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
| 2025 | Year | 01 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032012
