UMIN-CTR Clinical Trial

Basic information
Public title	Intestinal flora in patients with heart failure and the effects of guidance recommending probiotic food intake
Acronym	Intestinal flora in patients with heart failure and the effects of guidance recommending probiotic food intake
Scientific Title	An exploratory study examining the relationship between changes in intestinal flora and heart failure readmission rates provided by nutritional counseling that encourages the intake of probiotic foods in patients with heart failure
Scientific Title:Acronym	Intestinal flora in patients with heart failure and the effects of guidance recommending probiotic food intake
Region	Japan

Condition
Condition	heart failure
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the relationship between changes in intestinal flora and heart failure readmission rates provided by nutritional counseling that encourages the intake of probiotic foods in patients with heart failure
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Changes in stool culture test results 1 month after discharge
Key secondary outcomes	Heart failure symptoms and defecation status 1 month after discharge, changes in echocardiography and blood test results, and heart failure readmission rate 1 year after discharge

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Nutritional guidance by a dietitian will be assigned to groups that recommend the intake of probiotic foods.
Interventions/Control_2	Nutritional guidance by a dietitian will be assigned to groups that do not recommend the intake of probiotic foods.
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	Among patients hospitalized for heart failure, patients who have introduced a regional cooperation path for heart failure treatment
Key exclusion criteria	Patients with severe chronic diarrhea or chronic constipation, patients who are already taking probiotic drugs or dietary supplements, or patients who are receiving continuous antibiotics.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Yukio Middle name Last name Abe
Organization	Osaka City General Hospital
Division name	Cardiology
Zip code	534-0021
Address	2-13-22, Miyakojimahondori, Miyakojima-ku, Osaka city
TEL	06-6929-1221
Email	abeyukio@aol.com

Public contact
Name of contact person	1st name Yukio Middle name Last name Abe
Organization	Osaka City General Hospital
Division name	Cardiology
Zip code	534-0021
Address	2-13-22, Miyakojimahondori, Miyakojima-ku, Osaka city
TEL	06-6929-1221
Homepage URL
Email	abeyukio@aol.com

Sponsor
Institute	Osaka City General Hospital Department of Cardiology
Institute
Department

Funding Source
Organization	Japan Health Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka City General Hospital
Address	2-13-22, Miyakojimahondori, Miyakojima-ku, Osaka
Tel	06-6929-1221
Email	abeyukio@aol.com

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	2021 Year 04 Month 19 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	No longer recruiting
Date of protocol fixation	2020 Year 10 Month 09 Day
Date of IRB	2020 Year 10 Month 09 Day
Anticipated trial start date	2021 Year 04 Month 19 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 04 Month 11 Day
Last modified on	2022 Year 04 Month 12 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050118