UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028986
Receipt number R000032461
Scientific Title The effect of rifaximin on small intestinal motility and microbiota in patients with liver cirrhosis
Date of disclosure of the study information 2017/09/05
Last modified on 2022/03/13 16:46:42

* 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

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 or person

Institute

Division of Gastroenterology and Hepatology, Graduate School of Medical and Dental Sciences, Niigata University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032461


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name