UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024701 |
|---|---|
| Receipt number | R000028422 |
| Scientific Title | Novel approach to heart failure through the gut microbiota and its metabolite |
| Date of disclosure of the study information | 2017/01/01 |
| Last modified on | 2016/11/03 19:32:38 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Novel approach to heart failure through the gut microbiota and its metabolite
Acronym
Prevention and treatment of heart failure through the gut
Scientific Title
Novel approach to heart failure through the gut microbiota and its metabolite
Scientific Title:Acronym
Prevention and treatment of heart failure through the gut
Region
| Japan |
Condition
Condition
heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the characterization of gut microbial metabolites in the patients with heart failure.
To clarify prebiotics and probiotics which can prevent or treat heart failure.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To elucidate the characterization of gut microbial metabolites in the patients with heart failure.
Key secondary outcomes
Gut microbiota and its metabolites in feces after co-culture with prebioticas or probiotics in Kobe University Human Intestinal Model (KUHIM).
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
heart failure group
=patients diagnosed as heart failure
Control group
=patients who have heart failure risk factors such as hypertension, diabetes, and/or arrhythmia, but who do not have heart failure.
Key exclusion criteria
1) patients whose serum creatinine of greater than or equal to 3.0 mg/dL
2) patients with malignancy
3) patients with autoimmune disease or chronic inflammatory state
4) patients with inflammatory bowel diseases or intestinal surgery
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yamashita Tomoya |
Organization
Kobe University Hospital
Division name
Division of Cardiovascular Medicine
Zip code
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo 6500017, Japan
TEL
078-382-5111
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
Division of Cardiovascular Medicine
Zip code
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo 6500017, Japan
TEL
078-382-5111
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
Kobe university graduated school of science, technology, and innovation
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 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | 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 heart failure patients with various prebiotics/probiotics in Kobe University Human Intestinal Model. The purpose of this study is to clarify the characterization of gut microbial metabolite, and identify the prebiotics/probiotics which can lead gut microbiota and its metabolites considered to be heart failure protective.
Management information
Registered date
| 2016 | Year | 11 | Month | 03 | Day |
Last modified on
| 2016 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028422
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
