UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024009 |
|---|---|
| Receipt number | R000027646 |
| Scientific Title | Randomised control study evaluating the efficacy and the intestinal microbiota by perioperative administration of probiotics for liver transplant recipients |
| Date of disclosure of the study information | 2016/09/15 |
| Last modified on | 2019/09/17 11:20:11 |
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Basic information
Public title
Randomised control study evaluating the efficacy and the intestinal microbiota by perioperative administration of probiotics for liver transplant recipients
Acronym
Randomised control study evaluating the efficacy and the intestinal microbiota by perioperative administration of probiotics for liver transplant recipients
Scientific Title
Randomised control study evaluating the efficacy and the intestinal microbiota by perioperative administration of probiotics for liver transplant recipients
Scientific Title:Acronym
Randomised control study evaluating the efficacy and the intestinal microbiota by perioperative administration of probiotics for liver transplant recipients
Region
| Japan |
Condition
Condition
Liver transplant recipient
Classification by specialty
| Infectious disease | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the clinical efficacy of perioperative administration of probiotics for liver transplant recipients, stool samples will be analysed consecutively
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
surgical complications including infection, rejection, prognosis
Key secondary outcomes
Laboratory test results including blood examination and microbiological examination
Vital signs Prognosis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Administration of probiotics for 2 months or until discharge whichever longer.
Clostridium butyricum MIYAIRI 3g/day
Interventions/Control_2
No treatment
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
Liver transplant recipiets
>= 20 years old
Eligible for enteral feeding
Written informed consent
Key exclusion criteria
Those Who has a history of allergy to the drug
Those whom attending doctors regarded as inappropriate as candidates
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Ichiyama |
Organization
Kyoto University Hospital
Division name
Department of clinical laboraoty
Zip code
6068507
Address
Shogoin kawaharacho 54, Sakyo, Kyoto
TEL
075-751-3111
ict@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Miki |
| Middle name | |
| Last name | Nagao |
Organization
Kyoto University Hospital
Division name
Department of clinical laboraoty
Zip code
6068507
Address
Shogoin kawaharacho 54, Sakyo, Kyoto
TEL
075-751-3111
Homepage URL
ict@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University
Address
54 Shogoin kawahara-cho, Sakyo
Tel
075-751-3111
ethcom@kuhp.kyoto-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
JMA-IIA00249
Org. issuing International ID_1
JMA CCT
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
京都大学医学部附属病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 15 | 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
33
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
| 2016 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 12 | Day |
Last modified on
| 2019 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027646
