UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Bifidobacterium consumption on IgA production in low birth weight infant
Title of the study (Brief title)	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	Ouki Furukawa
Organization	Shiga University of Medical Science
Division name	Department of Pediatrics
Address	Tsukinowa, Seta, Otsu, Shiga
TEL	077-548-2553
Email	ouki@belle.shiga-med.ac.jp

Public contact
Name of contact person	Ouki Furukawa
Organization	Shiga University of Medical Science
Division name	Department of Pediatrics
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 01 Month 04 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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