UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038284 |
|---|---|
| Receipt number | R000043638 |
| Scientific Title | The interaction between gut microbiota and abdominal aortic aneurysm |
| Date of disclosure of the study information | 2019/10/15 |
| Last modified on | 2025/04/17 15:36:33 |
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Basic information
Public title
The interaction between gut microbiota and abdominal aortic aneurysm
Acronym
Gut microbiota and abdominal aortic aneurysm
Scientific Title
The interaction between gut microbiota and abdominal aortic aneurysm
Scientific Title:Acronym
Gut microbiota and abdominal aortic aneurysm
Region
| Japan |
Condition
Condition
Abdominal aortic aneurysm
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 abdominal aortic aneurysm, compared with controls without abdominal aortic aneurysm
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 abdominal aortic aneurysm
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 abdominal aortic aneurysm
Key exclusion criteria
Ruptured, traumatic, inflammatory, infectious, and congenital abdominal aortic aneurysm
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Eisaku |
| Middle name | |
| Last name | Ito |
Organization
The Jikei university Kashiwa Hospital
Division name
Vascular surgery
Zip code
277-8567
Address
163-1, Kashiwashita, Kashiwa-city, Chiba, 277-0004, Japan
TEL
0471641111
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
i_eisaku_ukasie@yahoo.co.jp
Sponsor or person
Institute
The Jikei university Kashiwa Hospital
Vascular surgery
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
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
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
| 2019 | Year | 10 | Month | 15 | 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
Main results already published
Date of protocol fixation
| 2018 | Year | 09 | Month | 29 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2024 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cohort study
Management information
Registered date
| 2019 | Year | 10 | Month | 13 | Day |
Last modified on
| 2025 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043638
