UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020520 |
|---|---|
| Receipt number | R000011657 |
| Scientific Title | effect of probiotics in low birth weight infant |
| Date of disclosure of the study information | 2016/04/14 |
| Last modified on | 2016/04/15 11:27:49 |
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Basic information
Public title
effect of probiotics in low birth weight infant
Acronym
probiotics in low birth weight infant
Scientific Title
effect of probiotics in low birth weight infant
Scientific Title:Acronym
probiotics in low birth weight infant
Region
| Japan |
Condition
Condition
low birth weight infant
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to clarify the impact of IgA secretion on probiotics in low birth weight infant
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
measurement of IgA and IgE in serum, and sIgA in stool at birth, 1month 2 month and 6month
Key secondary outcomes
measurement of IgG and IgM in serum in 1month 2 month and 6month
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
viable Bifidobacterium for six months
Interventions/Control_2
heat treated Bifidobacterium for six months
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 | months-old | <= |
Age-upper limit
| 6 | months-old | > |
Gender
Male and Female
Key inclusion criteria
Low birth weight infant (1500g-2500g)
Key exclusion criteria
severe congenital anomaly
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeki Koshida |
Organization
Shiga University of Medical Science
Division name
Department of Community Perinatal Medicine
Zip code
Address
Tsukinowa cho, Seta, Ohtsu, Shiga
TEL
077-548-2447
koshida@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeki Koshida |
Organization
Shiga University of Medical Science
Division name
Department of Community Perinatal Medicine
Zip code
Address
Tsukinowa cho, Seta, Ohtsu, Shiga
TEL
077-548-2447
Homepage URL
koshida@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science
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 | 04 | Month | 14 | 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
Completed
Date of protocol fixation
| 2012 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 11 | Day |
Last modified on
| 2016 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011657
