UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058121 |
|---|---|
| Receipt number | R000066432 |
| Scientific Title | The Impact of Hemodynamic and Lymphatic Circulatory Changes on the Gut Microbiota During Staged Surgical Palliation for Functional Single Ventricle |
| Date of disclosure of the study information | 2025/06/10 |
| Last modified on | 2025/06/09 10:56:37 |
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Basic information
Public title
The Impact of Hemodynamic and Lymphatic Circulatory Changes on the Gut Microbiota During Staged Surgical Palliation for Functional Single Ventricle
Acronym
The Impact of Hemodynamic and Lymphatic Circulatory Changes on the Gut Microbiota During Staged Surgical Palliation for Functional Single Ventricle
Scientific Title
The Impact of Hemodynamic and Lymphatic Circulatory Changes on the Gut Microbiota During Staged Surgical Palliation for Functional Single Ventricle
Scientific Title:Acronym
The Impact of Hemodynamic and Lymphatic Circulatory Changes on the Gut Microbiota During Staged Surgical Palliation for Functional Single Ventricle
Region
| Japan |
Condition
Condition
Functional single ventricle
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to elucidate the changes in the gut microbiota induced by Fontan circulation in the staged treatment of functional single ventricle heart disease, and to evaluate the significance of measuring these microbial changes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gut microbiota, gut microbiota alpha diversity, gut microbiota beta diversity, pulmonary artery pressure, superior vena cava pressure, inferior vena cava pressure, MRL, incidence of PLE
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
This study includes cases that underwent surgery with single ventricule surgery at the University of Toyama between January 1, 2005, and December 31, 2030.
Key exclusion criteria
Cases requiring emergency surgery
Cases with postoperative survival less than 7 days
Cases with a history of gastrointestinal disease
Cases that received antibiotic treatment within the past 3 months
Cases for which total cavopulmonary shunt (TCPS) surgery is indicated
Cases that the attending physician deems unsuitable for enrollment in this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Yoshimura |
Organization
University of Toyama
Division name
Department of Thoracic and Cardiovascular Surgery
Zip code
9300194
Address
2630 Sugitani,Toyama,Toyama
TEL
076-434-7330
ynaoki@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Toritsuka |
Organization
University of Toyama
Division name
Department of Thoracic and Cardiovascular Surgery
Zip code
9300194
Address
2630 Sugitani,Toyama,Toyama
TEL
0764347330
Homepage URL
dtoritsuka@gmail.com
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
University of Toyama
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee on Clinical and Epidemiological Research, University of Toyama
Address
2630 Sugitani,Toyama,Toyama
Tel
076-415-8857
rinri@adm.u-toyama.ac.jp
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
| 2025 | Year | 06 | Month | 10 | 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
| 2025 | Year | 06 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2035 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will retrospectively collect and compare outcomes of cases that underwent single ventlicule surgery at the University of Toyama between January 1, 2005, and December 31, 2030.
In addition to standard clinical practice, the only extra test will be fecal sample collection for gut microbiota analysis.
Participation in the study requires obtaining informed consent.
Management information
Registered date
| 2025 | Year | 06 | Month | 09 | Day |
Last modified on
| 2025 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066432
