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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024009
Receipt No. 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 2016/09/12

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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
Middle name
Last name Satoshi Ichiyama
Organization Kyoto University Hospital
Division name Department of clinical laboraoty
Zip code
Address Shogoin kawaharacho 54, Sakyo, Kyoto
TEL 075-751-3111
Email ict@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Miki Nagao
Organization Kyoto University Hospital
Division name Department of clinical laboraoty
Zip code
Address Shogoin kawaharacho 54, Sakyo, Kyoto
TEL 075-751-3111
Homepage URL
Email ict@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

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
Address
Tel
Email

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
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 Preinitiation
Date of protocol fixation
2016 Year 09 Month 12 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 01 Day
Last follow-up date
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
2016 Year 09 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027646

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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