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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044550
Receipt No. R000050896
Scientific Title Analysis of changes in bacterial flora in the upper gastrointestinal tract due to administration of Rifxima
Date of disclosure of the study information 2021/07/01
Last modified on 2021/06/15

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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