UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060766 |
|---|---|
| Receipt number | R000069417 |
| Scientific Title | A before-and-after comparative study of the efficacy of synbiotic supplementation in the acute phase of severe heart disease |
| Date of disclosure of the study information | 2026/03/31 |
| Last modified on | 2026/02/26 23:00:28 |
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Basic information
Public title
Efficacy of Synbiotic Supplementation in Acute Severe Cardiovascular Disease Patients
Acronym
Synbiotics in CCU
Scientific Title
A before-and-after comparative study of the efficacy of synbiotic supplementation in the acute phase of severe heart disease
Scientific Title:Acronym
Synbiotics in CCU
Region
| Japan |
Condition
Condition
severe cardiovascular disease
Classification by specialty
| Cardiology | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficasy of administering synbiotic supplementation to critically ill cardiac patients admitted to the CCU under acute ventilator management, along with the initiation of enteral nutrition, on gastrointestinal symptoms such as constipation and diarrhea, and infectious complications.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Occurrence of diarrhea (more than three watery stools per day), constipation (no bowel movements for more than three days), or infectious complications (respiratory-associated pneumonia, bacteremia, urinary tract infection, pseudomembranous enterocolitis) within 30 days after enrollment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Synbiotic supplementation (Synprotec, Yakult Honsha Co., Ltd.) will be administered three times a day via a nasogastric tube. The intervention will be continued during the patient's stay in the cardiac care unit, for up to a maximum of 10 days
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients with acute severe cardiac disease who required ventilator management and were admitted to our hospital's CCU and who were started on enteral nutrition via a nasogastric tube
Key exclusion criteria
Pregnant or nursing patients
Patients with medical conditions that preclude enteral nutrition (e.g., intestinal obstruction, gastrointestinal perforation)
Patients who have been continuously using synbiotic supplementation prior to the start of the study
Patients with a history of allergies to synbiotic supplementation
Patients (or their legal representatives) decline to participate in the study
Target sample size
360
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Nakayama |
Organization
Hyogo Prefectural Amagasaki General Medical Center
Division name
Department of Cardiology
Zip code
6608550
Address
2-17-77, Higashinaniwa, Amagasaki, Hyogo
TEL
0664807000
hersh.snf6@gmail.com
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Nakayama |
Organization
Hyogo Prefectural Amagasaki General Medical Center
Division name
Department of Cardiology
Zip code
660-8550
Address
2-17-77, Higashinaniwa, Amagasaki, Hyogo
TEL
06-6480-7000
Homepage URL
hersh.snf6@gmail.com
Sponsor or person
Institute
Hyogo Prefectural Amagasaki General Medical Center
Institute
Department
Personal name
Hiroyuki Nakayama
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo Prefectural Amagasaki General Medical Center
Address
2-17-77, Higashinaniwa, Amagasaki, Hyogo
Tel
06-6480-7000
hersh.snf6@gmail.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
| 2026 | Year | 03 | Month | 31 | 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
| 2023 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | 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
| 2026 | Year | 02 | Month | 26 | Day |
Last modified on
| 2026 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069417
