UMIN-CTR Clinical Trial

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
Email	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
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	Kyoto University
Address	54 Shogoin kawahara-cho, Sakyo
Tel	075-751-3111
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027646