UMIN-CTR Clinical Trial

Basic information
Public title	The effect of rifaximin on small intestinal motility and microbiota in patients with liver cirrhosis
Acronym	The changes of small intestinal motility and microbiota after the use of rifaximin
Scientific Title	The effect of rifaximin on small intestinal motility and microbiota in patients with liver cirrhosis
Scientific Title:Acronym	The changes of small intestinal motility and microbiota after the use of rifaximin
Region	Japan

Condition
Condition	Liver cirrhosis
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to compare small intestinal motility before and after the use of rifaximin in patients with liver cirrhosis by cine-MRI. Furthermore, we evaluate microbiota of the patients before and after the use of rifaximin and elucidate the relationship between microbiota and small intestinal motility.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The changes of small intestinal motility before and after administration of rifaximin for 4 weeks.
Key secondary outcomes	The changes of microbiota before and after administration of rifaximin for 4 weeks.

Base
Study type	Others,meta-analysis etc

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	99 years-old >
Gender	Male and Female
Key inclusion criteria	1. The patient who is older than 20 when the informed consent is obtained. 2. The patient who was diagnosed with liver cirrhosis and hepatic encephalopathy before the registration. 3. The administration of rifaximin is clinically appropriate. 4. The performance status of the patients is 0, 1, or 2. 5. The patient who is possible to be followed for 4 weeks after the administration of rifaximin. 6. The patient whose informed consent is obtained.
Key exclusion criteria	1. The patient who is pregnant or performing breast feeding. 2. The patient who was registered in this study before. 3. The patient who has allergy to rifaximin. 4. The patient who has colostomy or cannot collect stool correctly. 5. The patient who has severe constipation and a risk for ileus by preparation for cine-MRI. 6. The patient who has contraindications for MRI (i.e. a cardiac pace maker, claustrophobia, metal product in the body, etc.). 7. The patients who are judged by the investigators to be inappropriate participants in the trial.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shuji Terai
Organization	Graduate School of Medical and Dental Sciences, Niigata University
Division name	Division of Gastroenterology and Hepatology
Zip code
Address	757-1, Asahimachidori, Chuo-ku, Niigata-city, Niigata 951-8510, Japan
TEL	+81-25-223-2207
Email	terais@med.niigata-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Kazuya Takahashi
Organization	Graduate School of Medical and Dental Sciences, Niigata University
Division name	Division of Gastroenterology and Hepatology
Zip code
Address	757-1, Asahimachidori, Chuo-ku, Niigata-city, Niigata 951-8510, Japan
TEL	+81-25-223-2207
Homepage URL
Email	kazuya911@med.niigata-u.ac.jp

Sponsor
Institute	Division of Gastroenterology and Hepatology, Graduate School of Medical and Dental Sciences, Niigata 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
Address
Tel
Email

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	2017 Year 09 Month 05 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	Completed
Date of protocol fixation	2017 Year 08 Month 31 Day
Date of IRB	2017 Year 09 Month 05 Day
Anticipated trial start date	2017 Year 09 Month 05 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The aim of this study is to compare microbiota before and after the use of rifaximin in patients with liver cirrhosis. Furthermore, we evaluate the small intestinal motility by cine-MRI before and after the use of rifaximin and elucidate the relationship between microbiota and small intestinal motility.

Management information
Registered date	2017 Year 09 Month 04 Day
Last modified on	2022 Year 03 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032461