UMIN-CTR Clinical Trial

Basic information
Public title	Analysis of changes in bacterial flora in the upper gastrointestinal tract due to administration of Rifxima
Acronym	Analysis of changes in bacterial flora in the upper gastrointestinal tract due to administration of Rifxima
Scientific Title	Analysis of changes in bacterial flora in the upper gastrointestinal tract due to administration of Rifxima
Scientific Title:Acronym	Analysis of changes in bacterial flora in the upper gastrointestinal tract due to administration of Rifxima
Region	Japan

Condition
Condition	Patients with cirrhosis with hepatic encephalopathy
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Examine the effect of rifaximin on the bacterial flora of the upper gastrointestinal tract in patients with hyper ammoniaemia
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Changes in the bacterial flora of gastrointestinal tract after administration of rifaximin
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	It is intended for those who have hepatic encephalopathy with hyperammonemia between the ages of 20 and 90 and who are scheduled to receive rifaximin and who undergo upper gastrointestinal endoscopy.
Key exclusion criteria	When the research subject offers to decline participation in the research or withdraws consent When the entire research is canceled When discontinuing due to unfavorable events such as side effects When the person in charge of research determines that it is appropriate to discontinue the research for other reasons.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Shunhei Middle name Last name Yamashina
Organization	Juntendo University
Division name	Department of Gastroenterology
Zip code	1138421
Address	2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL	+81339957685
Email	syamashi@juntendo.ac.jp

Public contact
Name of contact person	1st name Shunhei Middle name Last name Yamashina
Organization	Juntendo University
Division name	Gastroenterology
Zip code	1138421
Address	2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL	+81339957685
Homepage URL
Email	syamashi@juntendo.ac.jp

Sponsor
Institute	Juntendo University
Institute
Department

Funding Source
Organization	ASKA Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Juntendo University
Address	2-1-1 Hongo, Bunkyo-ku, Tokyo
Tel	+81339957685
Email	syamashi@juntendo.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	順天堂大学医学部附属順天堂医院（東京都）

Other administrative information
Date of disclosure of the study information	2021 Year 07 Month 01 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	2021 Year 04 Month 12 Day
Date of IRB	2021 Year 05 Month 06 Day
Anticipated trial start date	2021 Year 05 Month 07 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry	2022 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information	Duodenal secretions are collected, RNA is extracted from the secretions, 16S rDNA (bacterial gene) is detected by real-time PCR, and intestinal bacteria are identified by sequence analysis (bacterial gene analysis).

Management information
Registered date	2021 Year 06 Month 15 Day
Last modified on	2021 Year 06 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050896