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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033114
Receipt No. R000037763
Scientific Title A randomised controlled trial on prevention of colonization of Staphylococcus aureus in neonates using multiple Bifidobacteria
Date of disclosure of the study information 2018/06/22
Last modified on 2018/06/28

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Basic information
Public title A randomised controlled trial on prevention of colonization of Staphylococcus aureus in neonates using multiple Bifidobacteria
Acronym Preventive effect of multiple Bifidobacteria on colonization of S. aureus in neonates
Scientific Title A randomised controlled trial on prevention of colonization of Staphylococcus aureus in neonates using multiple Bifidobacteria
Scientific Title:Acronym Preventive effect of multiple Bifidobacteria on colonization of S. aureus in neonates
Region
Japan

Condition
Condition Prevention of colonization of S. aureus
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to compare effect of one strain of Bifidobacterium vs 3 strains of Bifidobacterium on S. aureus colonization in low birth weight infants.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Colonization rate of S. aureus in specimens collected in feces, pharynx (nasal culture) up to 4 weeks after birth in each group.
Key secondary outcomes Measurement of the numbers of three strains Bifidobacterium and Staphylococcus aureus in each group in feces collected at 1 week, 2 weeks and 4 weeks after birth.
Difference between the age of each group and birth weight reversion
Correlation between weight gain rate and each group at week 40 weeks in preterm infants

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Administration of three bacterial species of Bifidobacterium
Interventions/Control_2 Administration of one bacterial spece of Bifidobacterium.
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

Not applicable
Gender Male and Female
Key inclusion criteria Less than 2,000g of low birth weight infants who were admitted to NICU and GCU.
Key exclusion criteria 1) Neonate whose birth weight is 2000g or more.
2) Infants with a surgical disease (esophageal atresia, diaphragmatic hernia, etc.), long-term enteral nutrition / oral medication administration can not be expected.
3) Neonate who judged to be ineligible by research facility director or research doctor.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Shimojo
Organization Chiba University School of Medicine
Division name Department of Pediatrics
Zip code
Address 1-8-1 Inohana Chiba, Chuo-ku, Japan
TEL 043-222-7171
Email shimojo@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Haruka Takei
Organization Chiba University Hospital
Division name Department of Pediatrics
Zip code
Address 1-8-1 Inohana Chiba, Chuo-ku, Japan
TEL 043-222-7171
Homepage URL
Email kagawaharukah@hotmail.co.jp

Sponsor
Institute Chiba University
Institute
Department

Funding Source
Organization Chiba University
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
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

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 22 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
2018 Year 06 Month 20 Day
Date of IRB
Anticipated trial start date
2018 Year 07 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
2018 Year 06 Month 22 Day
Last modified on
2018 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037763

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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