UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044550 |
|---|---|
| Receipt number | 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 20:28:25 |
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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
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
syamashi@juntendo.ac.jp
Sponsor or person
Institute
Juntendo 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
Juntendo University
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
Tel
+81339957685
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
Value
https://center6.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 | |
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| Registered date | File name |
