UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030213 |
|---|---|
| Receipt number | R000034509 |
| Scientific Title | Effect of Bifidobacterium consumption on IgA production in low birth weight infant |
| Date of disclosure of the study information | 2019/03/31 |
| Last modified on | 2017/12/01 14:36:13 |
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Basic information
Public title
Effect of Bifidobacterium consumption on IgA production in low birth weight infant
Acronym
Study of Bifidobacterium consumption in low birth weight infant
Scientific Title
Effect of Bifidobacterium consumption on IgA production in low birth weight infant
Scientific Title:Acronym
Study of Bifidobacterium consumption 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
Main objective of this study is to investigate if Bifidobacterium bifidum OLB6378 consumption enhances the fecal IgA level and saliva IgA level in Low birth weight infant. Secondary objective of this study is to investigate the effect of Bifidobacterium bifidum OLB6378 consumption on serum IgE level in low birth weight infant
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fecal IgA (1 month to 18 month age)
Key secondary outcomes
salivary IgA, IgA/protein,
salivary secretory component, secretory component/protein,
serum TGF, IL-10, IgE, Specific IgE,
allergy symptoms,
during 1 month to 18 month age
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Infant formula during hospitalization: Infant formula for low-birth weight infant added Bifidobacterium bifidum OLB6378
Infant formula after leaving hospital: Infant formula for term infant added Bifidobacterium bifidum OLB6378
Interventions/Control_2
Infant formula during hospitalization: Infant formula for low-birth weight infant
Infant formula after leaving hospital: Infant formula for term infant
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
| 1 | months-old | > |
Gender
Male and Female
Key inclusion criteria
1.infant whose birth weight: 1500g to 2500g
2.Infant who parents consent is obtained
Key exclusion criteria
1. severe bacterila infection
2. congenital anomaly
3. hospitalization more than 2 months
4. not suitabel for the trial defined by the attending neonatologist
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ouki Furukawa |
Organization
Shiga University of Medical Science
Division name
Department of Pediatrics
Zip code
Address
Tsukinowa, Seta, Otsu, Shiga
TEL
077-548-2553
ouki@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ouki Furukawa |
Organization
Shiga University of Medical Science
Division name
Department of Pediatrics
Zip code
Address
Tsukinowa, Seta, Otsu, Shiga
TEL
077-548-2553
Homepage URL
ouki@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Department of Pediatrics
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., Ltd.
Food Science & Technology Research Laboratory
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Meiji Co., Ltd.
Kyoto Prefectural University
Nihon University
Kyoto Institute of Nutrition & Pathology Inc.
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
滋賀医科大学医学部附属病院（滋賀県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | Month | 31 | 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
| 2016 | Year | 01 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 16 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 01 | Day |
Last modified on
| 2017 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034509
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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