UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023354 |
|---|---|
| Receipt number | 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 13:27:57 |
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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
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
tauchi@m.ehime-u.ac.jp
Sponsor or person
Institute
Ehime University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026702
