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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042124
Receipt No. R000048077
Scientific Title The interaction between gut microbiota and aortic dissection
Date of disclosure of the study information 2020/12/31
Last modified on 2021/01/17

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Basic information
Public title The interaction between gut microbiota and aortic dissection
Acronym Gut microbiota and aortic dissection
Scientific Title The interaction between gut microbiota and aortic dissection
Scientific Title:Acronym Gut microbiota and aortic dissection
Region
Japan

Condition
Condition Aortic dissection
Classification by specialty
Vascular surgery
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To clarify the composition of gut microbiota in patients with aortic dissection, compared with controls without aortic dissection
Basic objectives2 Others
Basic objectives -Others To clarify the change of gut microbiota during therapy and association of gut microbiota with prognosis in patients with aortic dissection
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Gut microbiota
Key secondary outcomes The metabolites of gut microbiota

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Untreated acute type B aortic dissection
Key exclusion criteria Ruptured, traumatic aortic dissection
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Eisaku
Middle name Ito
Last name Ito
Organization The Jikei university Kashiwa Hospital
Division name Vascular surgery
Zip code 277-0004
Address 163-1, Kashiwashita, Kashiwa-city, Chiba, 277-0004, Japan
TEL 0471641111
Email i_eisaku_ukasie@yahoo.co.jp

Public contact
Name of contact person
1st name Eisaku
Middle name
Last name Ito
Organization The Jikei university Kashiwa Hospital
Division name Vascular surgery
Zip code 277-0004
Address 163-1, Kashiwashita, Kashiwa-city, Chiba, 277-0004, Japan
TEL 0471641111
Homepage URL
Email i_eisaku_ukasie@yahoo.co.jp

Sponsor
Institute The Jikei university Kashiwa Hospital
Vascular surgery
Institute
Department

Funding Source
Organization Self funding
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 The Jikei University School of Medicine
Address 3-25-8, Nishishimbashi
Tel 0334331111
Email rinri@jikei.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
2020 Year 12 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 Open public recruiting
Date of protocol fixation
2020 Year 10 Month 12 Day
Date of IRB
2020 Year 10 Month 12 Day
Anticipated trial start date
2021 Year 01 Month 01 Day
Last follow-up date
2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Cohort study

Management information
Registered date
2020 Year 10 Month 14 Day
Last modified on
2021 Year 01 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048077

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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