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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035556
Receipt No. R000037174
Scientific Title Utility of the probiotics on the postoperative course of the open heart surgery in children
Date of disclosure of the study information 2019/01/16
Last modified on 2019/01/16

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Basic information
Public title Utility of the probiotics on the postoperative course of the open heart surgery in children
Acronym Utility of the probiotics on the postoperative course of the open heart surgery in children
Scientific Title Utility of the probiotics on the postoperative course of the open heart surgery in children
Scientific Title:Acronym Utility of the probiotics on the postoperative course of the open heart surgery in children
Region
Japan

Condition
Condition Congenital heart disease with biventricular anatomy
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of probiotics (BBG-01) on intestinal microflora ,intestinal permeability, and surgical outcome, after open heart surgery in children
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes changes in fecal microflora
changes in blood microflora
Key secondary outcomes

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 YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 BBG-01 administration
Interventions/Control_2 BBG-01 non-administration
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
15 years-old >=
Gender Male and Female
Key inclusion criteria 1.Patients who underwent open heart surgery
2.Child(0-15 years old)
3.Cases in which written informed consent was obtained from the substitute
Key exclusion criteria 1.Emergency case
2.Univentricular heart
3.Fontan candidate
4. Cases who died in 7 days after surgery
5. Cases who could not take BBG-01 for 7 days before surgery
6.Allegy for milk, potato, and corn
7.Associated with gastrointestinal disease
8. Cases in which the doctor judged that the registration in this study is inappropriate
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daisuke Toritsuka
Organization University of Toyama
Division name Department of Thoracic and Cardiovascular Surgery
Zip code
Address 2630 Sugitani,Toyama,Toyama
TEL 076-434-7330
Email dtori@med.u-toyama.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Toritsuka
Organization University of Toyama
Division name Department of Thoracic and Cardiovascular Surgery
Zip code
Address 2630 Sugitani,Toyama,Toyama
TEL 076-434-7330
Homepage URL
Email dtori@med.u-toyama.ac.jp

Sponsor
Institute University of Toyama
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor The Yakult Central Institute, Yakult Honsha Co, Ltd., Tokyo, Japan
Name of secondary funder(s)

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 富山大学病院(富山県)

Other administrative information
Date of disclosure of the study information
2019 Year 01 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 12 Month 19 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 17 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
2019 Year 01 Month 16 Day
Last modified on
2019 Year 01 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037174

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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