UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043829 |
|---|---|
| Receipt number | R000050021 |
| Scientific Title | Alterations of microbial composition in obstructed biliary stent based on 16SrRNA amplicon sequencing |
| Date of disclosure of the study information | 2021/04/02 |
| Last modified on | 2023/10/04 13:11:32 |
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Basic information
Public title
Alterations of microbial composition in obstructed biliary stent based on 16SrRNA amplicon sequencing
Acronym
Alterations of microbial composition in obstructed biliary stent based on 16SrRNA amplicon sequencing
Scientific Title
Alterations of microbial composition in obstructed biliary stent based on 16SrRNA amplicon sequencing
Scientific Title:Acronym
Alterations of microbial composition in obstructed biliary stent based on 16SrRNA amplicon sequencing
Region
| Japan |
Condition
Condition
Obstructive jaundice
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between stent occlusion severity and microbial composition in the lumen of biliary stent in patients who underwent endoscopic biliary drainage for obstructive jaundice
Basic objectives2
Others
Basic objectives -Others
Elucidation of pathogenesis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between stent occlusion severity and microbial composition in the lumen of biliary stent
Key secondary outcomes
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
Subjects who participated in the study entitled "Association of gut microbiota with inflammation, cancer, or dysfunction in gastrointestinal diseases UMIN000040192" from April 1, 2017 to March 31, 2019, and underwent microbiota analysis of biliary stents
Key exclusion criteria
Those who refused to participate by opting out
Target sample size
27
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Kawahara |
Organization
The Jikei University School of Medicine
Division name
Department of Endoscopy
Zip code
1058471
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo
TEL
0336331111
ms04furuhashi@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Hiroto |
| Middle name | |
| Last name | Furuhashi |
Organization
The Jikei University School of Medicine
Division name
Department of Endoscopy
Zip code
1058471
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo
TEL
0336331111
Homepage URL
ms04furuhashi@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Jikei University School of Medicine
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, Nishi-Shimbashi, Minato-ku, Tokyo
Tel
0336331111
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
| 2021 | Year | 04 | Month | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not applicable
Management information
Registered date
| 2021 | Year | 04 | Month | 02 | Day |
Last modified on
| 2023 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050021
