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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name