UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034529 |
|---|---|
| Receipt number | R000039370 |
| Scientific Title | The impact of laxatives on microbiome-related metabolites in patients with chronic heart failure |
| Date of disclosure of the study information | 2018/10/16 |
| Last modified on | 2018/10/17 18:56:34 |
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Basic information
Public title
The impact of laxatives on microbiome-related metabolites in patients with chronic heart failure
Acronym
Association between laxatives and gut microbial metabolites in heart failure
Scientific Title
The impact of laxatives on microbiome-related metabolites in patients with chronic heart failure
Scientific Title:Acronym
Association between laxatives and gut microbial metabolites in heart failure
Region
| Japan |
Condition
Condition
Heart Failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the impact of laxatives on circulating levels of microbiome-related metabolites in chronic heart failure patients with constipation
Basic objectives2
Others
Basic objectives -Others
To investigate the impact of laxatives on gut microbiome composition in chronic heart failure patients with constipation
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
microbiome-related metabolites
Key secondary outcomes
gut microbiota
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral inteke of usual dosage of laxatives once daily. 1 to 3-month intervention period.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Heart failure patients who were diagnosed by Framingham criteria and had constipation
Key exclusion criteria
Patients with renal failure, bowel diseases, or active infectious diseases
Target sample size
10
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, Japan
TEL
078-382-5846
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, Japan
TEL
078-382-5846
Homepage URL
tomoya@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine, Division of Cardiovascular Medicine, Department of Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tohoku University
Name of secondary funder(s)
None
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
| 2018 | Year | 10 | Month | 16 | 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
| 2018 | Year | 10 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 11 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 16 | Day |
Last modified on
| 2018 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039370
