UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030213
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email ouki@belle.shiga-med.ac.jp

Sponsor
Institute Shiga University of Medical Science

Department of Pediatrics
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034509

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.