UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016663 |
|---|---|
| Receipt number | 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 13:13:09 |
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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
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
yuki_kimura@tmhp.jp
Sponsor or person
Institute
Tokyo Metropolitan Childrens'medical center, department of Neonatology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019341
