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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000016663
Receipt No. R000019341
Scientific Title The effect of Bifidobacterium breve on immunologic parameters in low birth weight infants:An Open-label non-randomized controlled trial
Date of disclosure of the study information 2015/02/28
Last modified on 2015/05/06

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Basic information
Public title The effect of Bifidobacterium breve on immunologic parameters in low birth weight infants:An Open-label non-randomized controlled trial
Acronym The effect of Bifidobacterium breve on immunologic parameters in low birth weight infants:An Open-label non-randomized controlled trial
Scientific Title The effect of Bifidobacterium breve on immunologic parameters in low birth weight infants:An Open-label non-randomized controlled trial
Scientific Title:Acronym The effect of Bifidobacterium breve on immunologic parameters in low birth weight infants:An Open-label non-randomized controlled trial
Region
Japan

Condition
Condition Infants born with birth weight equal to or greater than 1500g, and less than 2000g
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine whether the oral application of Bifidobacterium breve may improve selected immunological parameters of intestinal inflammation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes evaluate the fecal calprotectin concentration at day7 and day21.
Key secondary outcomes Evaluate the composition of intestinal flora on day0, 7, 21.
Immunologic parameters such as fecal IgA concentration, serum cytokines, serum high sensitive CRP will be checked on day7 and 21.
Body weight and feeding intolerance will be checked every day until day21.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Bifidobacterium breve M-16V will be dissolved in water and amout of 0.5ml will be given within 24 hours after birth.
The infants will receive probiotics once a day, for 21 days.
Interventions/Control_2 No application
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
1 days-old >
Gender Male and Female
Key inclusion criteria Infants whose birth weight is equal to or greater than 1500g and less than 2000g, who were admitted to our hospital within 21 hours after birth.
Key exclusion criteria Newborns with chromosomal anomaly, multiple congenital anomaly, congenital heart disease, congenital anomaly of intestine, and those who were judged inappropriate by the principal investigator
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuki Kimura
Organization Tokyo Metropolitan Childrens'medical center
Division name Neonatology
Zip code
Address 2-8-29, Musashidai, Fuchu-city, Tokyo
TEL 042-300-5111
Email yuki_kimura@tmhp.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuki Kimura
Organization Tokyo Metropolitan Childrens'medical center
Division name Neonatology
Zip code
Address 2-8-29, Musashidai, Fuchu-city, Tokyo
TEL 042-300-5111
Homepage URL
Email yuki_kimura@tmhp.jp

Sponsor
Institute Tokyo Metropolitan Childrens'medical center, department of Neonatology
Institute
Department

Funding Source
Organization Tokyo Metropolitan Childrens'medical center
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) Morinaga milk industry

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
2015 Year 02 Month 28 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 Enrolling by invitation
Date of protocol fixation
2015 Year 02 Month 26 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 06 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
2015 Year 02 Month 27 Day
Last modified on
2015 Year 05 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019341

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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