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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023354
Receipt No. R000026702
Scientific Title Effects of Bifidobacterium breve (BBG-01) administration in Neonatal Intensive Care Unit cared preterm infants to gain enterobacterial flora
Date of disclosure of the study information 2016/08/15
Last modified on 2016/07/27

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Basic information
Public title Effects of Bifidobacterium breve (BBG-01) administration in Neonatal Intensive Care Unit cared preterm infants to gain enterobacterial flora
Acronym Effects of Bifidobacterium breve (BBG-01) administration in Neonatal Intensive Care Unit cared preterm infants
Scientific Title Effects of Bifidobacterium breve (BBG-01) administration in Neonatal Intensive Care Unit cared preterm infants to gain enterobacterial flora
Scientific Title:Acronym Effects of Bifidobacterium breve (BBG-01) administration in Neonatal Intensive Care Unit cared preterm infants
Region
Japan

Condition
Condition Neonatal Intensive Care Unit cared preterm infants
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will evaluate the effects of B. breve administration for early development of bifidobacteria dominated microbiota in Neonatal Intensive Care Unit cared preterm infants.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Early development of bifidobacteria dominated microbiota
Key secondary outcomes Weight gain, diseases prevention, and infants' health

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
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 Prevention
Type of intervention
Food
Interventions/Control_1 BBG-01
Interventions/Control_2 BBG-01
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
0 days-old <=
Age-upper limit
28 days-old >=
Gender Male and Female
Key inclusion criteria BBG-01
Key exclusion criteria BBG-01
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisamichi Tauchi
Organization Ehime University Graduate School of Medicine
Division name Department of Pediatrics
Zip code
Address Shitsukawa, Toon, Ehime
TEL 089-960-5320
Email tauchi@m.ehime-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hisamichi Tauchi
Organization Ehime University Graduate School of Medicine
Division name Department of Pediatrics
Zip code
Address Shitsukawa, Toon, Ehime
TEL 089-960-5320
Homepage URL
Email tauchi@m.ehime-u.ac.jp

Sponsor
Institute Ehime University Graduate School of Medicine
Institute
Department

Funding Source
Organization Ehime University Graduate School of Medicine
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
2016 Year 08 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 01 Month 25 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 15 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 07 Month 27 Day
Last modified on
2016 Year 07 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026702

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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