UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051435 |
|---|---|
| Receipt number | R000058671 |
| Scientific Title | Alternation of gut microbiota by perioperative medicine for congenital heart disease: a observational study |
| Date of disclosure of the study information | 2023/06/23 |
| Last modified on | 2024/01/22 13:45:27 |
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Basic information
Public title
Alternation of gut microbiota by perioperative medicine for congenital heart disease: a observational study
Acronym
Alternation of gut microbiota by congenital heart disease surgery
Scientific Title
Alternation of gut microbiota by perioperative medicine for congenital heart disease: a observational study
Scientific Title:Acronym
Alternation of gut microbiota by congenital heart disease surgery
Region
| Japan |
Condition
Condition
Congenital heart disease
Classification by specialty
| Cardiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the alternation of gut microbiota caused by perioperative medicine for congenital heart disease in neonates and infants.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The alternation of gut microbiota alpha- or beta-diversity between preoperative period and 7days after surgery.
Key secondary outcomes
The alternation of the relative abundances of bacteria between preoperative period and 7days after surgery.
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
| 1 | days-old | <= |
Age-upper limit
| 1 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Neonates and infants who undergo the surgery for congenital heart disease
Key exclusion criteria
Children who have gastrointestinal disease
Children who eat baby food
Children who has a history of surgery or receiving antibiotics
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | Ohba |
Organization
Hokkaido Medical Center for Child Health and Rehabilitation
Division name
Intensive care department
Zip code
060-0041
Address
240-6, Kanayama 1 jo, 1 cho-me, Teine-ku, Sapporo, Hokkaido
TEL
011-694-5696
obajun@gmail.com
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Chaki |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Anesthesiology
Zip code
060-8543
Address
291, South 1, West 16, Chuo-ku, Sapporo, Hokkaido
TEL
011-611-2111
Homepage URL
chakitomohiro0728@yahoo.co.jp
Sponsor or person
Institute
Hokkaido Medical Center for Child Health and Rehabilitation
Institute
Department
Personal name
Funding Source
Organization
Hokkaido Medical Center for Child Health and Rehabilitation
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
Institutional review board of Hokkaido Medical Center for Child Health and Rehabilitation
Address
291, South 1, West 16, Chuo-ku, Sapporo, Hokkaido
Tel
011-691-5696
obajun@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
| 2023 | Year | 06 | Month | 23 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 23 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, the change of gut microbiota during perioperative period is going to be analyzed and evaluated.
Management information
Registered date
| 2023 | Year | 06 | Month | 23 | Day |
Last modified on
| 2024 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058671
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
