UMIN-CTR Clinical Trial

Basic information
Public title	Study on the effect of rifaximin on cirrhosis
Acronym	Rifaximin in cirrhosis
Scientific Title	Study on the effect of rifaximin on cirrhosis
Scientific Title:Acronym	Rifaximin in cirrhosis
Region	Japan

Condition
Condition	Hepatic encephalopathy (Overt encephalopathy, Covert encephalopathy) Hyperammonemia
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the usefulness and efficacy predictors of rifaximin in cases of liver cirrhosis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in ammonia levels due to rifaximin administration
Key secondary outcomes	1.Changes in hepatic encephalopathy symptoms before and after administration of rifaximin 2.Changes in NP-test test results before and after administration of rifaximin 3.Changes in bacterial translocation markers before and after administration of rifaximin 4.Changes in muscle mass before and after administration of rifaximin 5.Changes in fecal bacterial flora before and after administration of rifaximin 6.Correlation between ammonia value, various blood test values, and NP-test results 7.Correlation between ammonia value and bacterial translocation marker 8.Correlation between ammonia level and endotoxin and preceptin 9.Relationship between ammonia level and fecal bacterial flora

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	1.Those who are 20 years old or older at the time of obtaining consent 2. Liver disease patients with hyperammonemia (70 g / dl or more) 3. Those who have voluntarily consented to participate in this study
Key exclusion criteria	1.Persons with pulmonary tuberculosis and other tuberculosis 2.Those who are pregnant or breastfeeding 3.Those who have been diagnosed with pseudomembranous enteritis 4.Others who are judged by the principal investigator or coordinator to be inappropriate as research subjects
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Masato Middle name Last name Nakai
Organization	Hokkaido University Hospital
Division name	Gastroenterology and Hepatology
Zip code	0608638
Address	Kita-15, Nishi-7, Kita-ku,Sapporo,Hokkaido
TEL	0117161161
Email	mnakai@pop.med.hokudai.ac.jp

Public contact
Name of contact person	1st name Masato Middle name Last name Nakai
Organization	Hokkaido University Hospital
Division name	Gastroenterology and Hepatology
Zip code	0608638
Address	Kita-15, Nishi-7, Kita-ku,Sapporo,Hokkaido
TEL	0117161161
Homepage URL
Email	mnakai@pop.med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University Hospital
Institute
Department

Funding Source
Organization	Self-funding
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	Hokkaido University Hospital Division of Clinical Research Administration
Address	Kita-15, Nishi-7, Kita-ku, Sapporo, Hokkaido
Tel	0117067636
Email	crjimu@huhp.hokudai.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 05 Month 10 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 01 Month 30 Day
Date of IRB	2018 Year 02 Month 02 Day
Anticipated trial start date	2018 Year 02 Month 05 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2023 Year 06 Month 30 Day
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2021 Year 05 Month 08 Day
Last modified on	2022 Year 09 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050398