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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043829
Receipt No. 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 2021/04/02

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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
Email 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
Email ms04furuhashi@jikei.ac.jp

Sponsor
Institute The Jikei University School of Medicine
Institute
Department

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
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
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
2020 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
2021 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050021

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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