UMIN-CTR Clinical Trial

Basic information
Public title	Effect of Bifidobacterium administration on fecal IgA in full-term infants: a randomized control pilot trial
Acronym	Fecal IgA in full-term infants who take Bifidobacterium trial
Scientific Title	Effect of Bifidobacterium administration on fecal IgA in full-term infants: a randomized control pilot trial
Scientific Title:Acronym	Fecal IgA in full-term infants who take Bifidobacterium trial
Region	Japan

Condition
Condition	normal birth-weight and full-term infant
Classification by specialty	Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this pilot trial is to calculate the sample size of the future main study. For this porpous, means and standard deviations of fecal IgA of two groups of infants, who use infant formula with or without Bifidobaterium.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Fecal IgA level of infants
Key secondary outcomes	The number of Bifidobacterium bifidum in infant feces Frequency of eczema in the study infants

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	A group: The test formula is the infant formula containing heat-treated Bifidobacterim bifidum OLB6378
Interventions/Control_2	C group: The infant formula without Bifidobacterium bifidum OLB6378. It is indistinguishable from the test infantformula in appearance.
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	2 days-old >=
Gender	Male and Female
Key inclusion criteria	1. normal birth-weight (2,500 g <= birth-weight < 4,000 g ) infant and his/her mother 2. full-term (37 weeks <= gestational age < 42 weeks) infant and his/her mother 3. Signed consent form to participate in the study was obtained from the infant's mother as the legal representative after full explanation of this study and its ethical considerations to persons in parental authority.
Key exclusion criteria	1. infant with severe infection and his/her mother 2. infant with severe congenital abnormality and his/her mother 3. infant who is considered unsuitable subjects by the attending physician and his/her mother
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Naoki Shimojo
Organization	Chiba University
Division name	Graduate School of Medicine
Zip code
Address	1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8670, JAPAN
TEL	043-226-2144
Email	shimojo@faculty.chiba-u.jp

Public contact
Name of contact person	1st name Middle name Last name Hiroki Takayama
Organization	Soiken Inc.
Division name	Clinical Study Support Division
Zip code
Address	NBF Ogawamachi Building 4F, 1-3-1 Ogawamachi, Kanda, Chiyoda-ku, Tokyo
TEL	03-3295-1350
Homepage URL
Email	takayama@soiken.com

Sponsor
Institute	Graduate School of Medicine, Chiba University
Institute
Department

Funding Source
Organization	Meiji Co. Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2019 Year 05 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	Completed
Date of protocol fixation	2018 Year 03 Month 07 Day
Date of IRB	2018 Year 03 Month 07 Day
Anticipated trial start date	2018 Year 03 Month 07 Day
Last follow-up date	2019 Year 07 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 07 Month 05 Day
Last modified on	2020 Year 01 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037815