UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000035556 |
|---|---|
| Receipt number | 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 | 2024/01/19 19:19:03 |
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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 | 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
076-434-7330
dtoritsuka@gmail.com
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
076-434-7330
Homepage URL
black11@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
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
Toyama university hospital Center for clinical research
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
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
no
Publication of results
Partially published
Result
URL related to results and publications
no
Number of participants that the trial has enrolled
82
Results
The total number of obligate anaerobes was higher in the intervention group after post operative day7.
Facal organic acids did not differ between the two groups, but were decreased by the surgery
Bacterial translocation occurred in about 40% of both groups.
I-FABP did not differ between the two groups, but were elevated in the early postoperative period.
Inflammation markers except IL-17A did not differ between the two groups
Results date posted
| 2024 | Year | 01 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patient background did not differ between the two groups, and there were no perioperative deaths.
Participant flow
The patients were randomly allocated to two groups: the intervention group (IG) (n=41) received BBG-01 after every meal 3 times a day every 7 days just before surgery and from post-operative day 1 to discharge, and the control group (CG) (n=41) did not receive BBG-01 treatment. All patients received perioperative antibiotic prophylaxis from the day of surgery until postoperative day 2
Adverse events
No adverse events
Outcome measures
Fecal microbiota
Measurements of fecal organic acid concentrations and pH
Blood microbiota
I-FABP levels
Blood cell counts, lymphocyte subsets, and plasma cytokine and inflammation biomarker
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2018 | Year | 12 | Month | 19 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 05 | Month | 17 | Day |
Date trial data considered complete
| 2021 | Year | 05 | Month | 17 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 16 | Day |
Last modified on
| 2024 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037174
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| Registered date | File name |
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