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 |
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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
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
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
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
