UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048778 |
|---|---|
| Receipt number | R000055574 |
| Scientific Title | Investigation of improvement of sarcopenia by suppression of hyperammonemia with rifaximin. |
| Date of disclosure of the study information | 2022/08/28 |
| Last modified on | 2024/03/04 13:01:11 |
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Basic information
Public title
Investigation of improvement of sarcopenia by suppression of hyperammonemia with rifaximin.
Acronym
Investigation of improvement of sarcopenia by suppressing hyperammonemia
Scientific Title
Investigation of improvement of sarcopenia by suppression of hyperammonemia with rifaximin.
Scientific Title:Acronym
Investigation of improvement of sarcopenia by suppression of hyperammonemia with rifaximin.
Region
| Japan |
Condition
Condition
cirrhotic patient
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether correction of hyperammonemia with rifaximin improves sarcopenia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Grip strength after 12 weeks of rifaximin administration
Key secondary outcomes
Skeletal muscle index after 12 weeks of rifaximin administration
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Fasting blood ammonia level
2) Normal cognitive function
3) Child Pugh score of 9 or less
4)Patients expected to survive at least 12 months
5)Independent in ADL.
Key exclusion criteria
1) Patients with liver cancer in more advanced stage than BCLC-C stage
2) Patients who will be treated for hepatocellular carcinoma within the study period.
3) Patients with serious bone or muscle disease or cardiac, pulmonary, renal, or cerebrovascular disease.
4) Pregnant or lactating women and patients who may or intend to become pregnant.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Matsumoto |
Organization
Iwate Medical University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine.
Zip code
028-3695
Address
Idaidori 2-1-1, Yahaba, Iwate
TEL
+81-19-613-7111
tmatumo@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Endo |
Organization
Iwate Medical University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine.
Zip code
028-3695
Address
Idaidori 2-1-1, Yahaba, Iwate
TEL
+81196137111
Homepage URL
keiendo@iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Iwate Medical University School of Medicine
Address
Idaidori 2-1-1, Yahaba, Iwate
Tel
019-651-5110
kenkyu-rinri@j.iwate-med.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 28 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2022 | Year | 08 | Month | 28 | Day |
Last modified on
| 2024 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055574
