UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000007143
Receipt No. R000008412
Scientific Title Efficacy of probiotics for infants with congenital heart disease
Date of disclosure of the study information 2012/01/30
Last modified on 2012/08/27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Efficacy of probiotics for infants with congenital heart disease
Acronym Efficacy of probiotics for infants
Scientific Title Efficacy of probiotics for infants with congenital heart disease
Scientific Title:Acronym Efficacy of probiotics for infants
Region
Japan

Condition
Condition Patients scheduled for pediatric cardiovascular surgery
Classification by specialty
Cardiovascular surgery Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Maintenance of intestinal environment and prevention of perioperative infectious complications
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Intestinal microflora
Intestinal environment
Postoperative complications
Key secondary outcomes Length of pediatric intensive care unit
Gastrointestinal function

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Bifidobacterium breve
Interventions/Control_2 placebo
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

Not applicable
Age-upper limit
1 months-old >
Gender Male and Female
Key inclusion criteria Infants who will undergo operations at the Department of pediatrics cardiovascular surgery of Kyoto prefectural University of medicine
Key exclusion criteria -A subject whose operation is cancelled.
-A subject who is not suitable for the trial defined by the attending researcher.
Target sample size 60

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Nobuaki Shime
Organization Kyoto prefectural university of medicine
Division name Intensive care unit
Zip code
Address 465 Kajii-cho, kamigyo-ku, Kyoto, Japan. 602-8566
TEL 075-251-5633
Email

Public contact
1st name of contact person
1st name
Middle name
Last name Takako Umenai
Organization Kyoto Prefectural university of medicine
Division name Intensive care unit
Zip code
Address 465 Kajii-cho, kamigyo-ku, Kyoto, Japan. 602-8566
TEL 075-251-5633
Homepage URL
Email takako@koto.kpu-m.ac.jp

Sponsor
Institute Department of Anesthesiology, Kyoto prefectural university of medicine
Institute
Department

Funding Source
Organization nothing
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Yakult Honsya Co. Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 京都府立医科大学附属病院

Other administrative information
Date of disclosure of the study information
2012 Year 01 Month 30 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 Suspended
Date of protocol fixation
2007 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
2012 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 01 Month 26 Day
Last modified on
2012 Year 08 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008412

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.