UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005412 |
|---|---|
| Receipt number | R000006421 |
| Scientific Title | Efficacy of early administration of BBG-01 (Bifidobacterium breve) on growth and development of preterm infants in NICU |
| Date of disclosure of the study information | 2011/04/08 |
| Last modified on | 2011/04/08 16:35:12 |
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Basic information
Public title
Efficacy of early administration of BBG-01 (Bifidobacterium breve) on growth and development of preterm infants in NICU
Acronym
Efficacy of BBG-01 administration for preterm infants
Scientific Title
Efficacy of early administration of BBG-01 (Bifidobacterium breve) on growth and development of preterm infants in NICU
Scientific Title:Acronym
Efficacy of BBG-01 administration for preterm infants
Region
| Japan |
Condition
Condition
very low birth weight (VLBW) infants and
extremely low birth weight (ELBW) infants
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Promotion of growth and development in preterm infants
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Body weight, height, head circumference,
vital sign
Key secondary outcomes
Fatty acids in blood
Intestinal microbiota and intestinal environment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Bifidobacterium breve
Interventions/Control_2
Placebo
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
| 0 | weeks-old | > |
Gender
Male and Female
Key inclusion criteria
VLBW infants and ELBW infants
Key exclusion criteria
A lethal congenital abnormality known at trial entry.
Any known gastrointestinal malformation.
No realistic prospect of survival.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichiro Yamashiro |
Organization
Juntendo University,
Division name
Division of Laboratory for Probiotic Research
Zip code
Address
3rd Floor, Hongo-Asakaze Bldg, 2-9-8, Hongo, Bunkyo-ku, Tokyo 113-0033, Japan
TEL
03-3813-3111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichiro Yamashiro |
Organization
Juntendo University,
Division name
Division of Laboratory for Probiotic Research
Zip code
Address
3rd Floor, Hongo-Asakaze Bldg, 2-9-8, Hongo, Bunkyo-ku, Tokyo 113-0033, Japan
TEL
03-3813-3111
Homepage URL
Sponsor or person
Institute
Division of Laboratory for Probiotic Research, Juntendo University,
Institute
Department
Personal name
Funding Source
Organization
Division of Laboratory for Probiotic Research, Juntendo University,
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Okinawa Prefectural Nanbu Medical Center & Children's Medical Center
Name of secondary funder(s)
Yakult Honsha Co.Ltd
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
沖縄県立南部医療センター・こども医療センター（沖縄県）/Okinawa Prefectural Nanbu Medical Center & Children's Medical Center(Okinawa)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 04 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | 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
| 2011 | Year | 04 | Month | 08 | Day |
Last modified on
| 2011 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006421
