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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034529
Receipt No. 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

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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
Email 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
Email tomoya@med.kobe-u.ac.jp

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

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039370

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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