UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The impact of laxatives on microbiome-related metabolites in patients with chronic heart failure
Title of the study (Brief title)	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	Tomoya Yamashita
Organization	Kobe University Graduate School of Medicine
Division name	Division of Cardiovascular Medicine, Department of Internal Medicine
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	Tomoya Yamashita
Organization	Kobe University Graduate School of Medicine
Division name	Division of Cardiovascular Medicine, Department of Internal Medicine
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

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 10 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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