UMIN-CTR Clinical Trial

Basic information
Public title	Effect of Bifidobacterium bifidum supplementation on growth and development of term infants at 1 year of age
Acronym	Effect of Bifidobacterium on growth and development of term infants
Scientific Title	Effect of Bifidobacterium bifidum supplementation on growth and development of term infants at 1 year of age
Scientific Title:Acronym	Effect of Bifidobacterium on growth and development of term infants
Region	Japan

Condition
Condition	Term infants
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To test the efficacy of Bifidobacterium bifidum OLB6378 on morbidities during the first year , and growth and development at 1 year of age among term infants
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase I,II

Assessment
Primary outcomes	Morbidities during the first year of life
Key secondary outcomes	Growth and development at 1 year of age

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Bifidobacterium bifidum OLB6378 powder (Meiji Co., Ltd., Tokyo, Japan) (0.5g/package) is administered twice a day, and continued until 1 month after birth
Interventions/Control_2	No administration
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	1 months-old <=
Age-upper limit	12 months-old >=
Gender	Male and Female
Key inclusion criteria	Term infants
Key exclusion criteria	Infants with complications
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Satoshi Middle name Last name Kusuda
Organization	NPO Neonatal Research Network
Division name	Headquaters
Zip code	110-0015
Address	Higashiueno
TEL	0338350435
Email	skusuda@boshi.twmu.ac.jp

Public contact
Name of contact person	1st name Satoshi Middle name Last name Kusuda
Organization	kyorindai university
Division name	Headquaters
Zip code	110-0015
Address	Higashiueno
TEL	0338350435
Homepage URL
Email	kusuda-satoshi@umin.ac.jp

Sponsor
Institute	NPO Neonatal Research Network
Institute
Department

Funding Source
Organization	NPO Neonatal Research Network
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Shiseikai Daini Hospital Tokyo Women's Medical University Maternal and Perinatal Center Meiji Milk Company
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Shiseikai 2nd Hospital IRB
Address	5-19-1 Kamisoshigaya, Setagaya, Tokyo
Tel	03-3300-3666
Email	kusuda-satoshi@umin.ac.jp

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	至誠会第二病院

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 11 Day

Related information
URL releasing protocol	https://britishjournalofgastroenterology.com/
Publication of results	Published

Result
URL related to results and publications	https://britishjournalofgastroenterology.com/
Number of participants that the trial has enrolled	44
Results	In total, 44 infants were enrolled in this study, 21 in the Control (CG) and 23 in the Intervention (IG). Data of 17 infants in the CG and 18 in the IG were analyzed. Groth and developmental quotients at one year of age were not statistically different between the groups. However, infants in the IG had significantly fewer days without defecation.
Results date posted	2022 Year 08 Month 09 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2022 Year 04 Month 01 Day
Baseline Characteristics	21 in the Control Group and 23 in the Intervention Group.
Participant flow	Follow-up until 1 year old after the enrollment in the study,
Adverse events	None
Outcome measures	Growth, neurological development, and defecation status
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2017 Year 07 Month 31 Day
Date of IRB	2017 Year 08 Month 01 Day
Anticipated trial start date	2017 Year 08 Month 01 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry	2020 Year 01 Month 31 Day
Date trial data considered complete	2020 Year 02 Month 01 Day
Date analysis concluded	2020 Year 02 Month 28 Day

Other
Other related information

Management information
Registered date	2017 Year 09 Month 11 Day
Last modified on	2022 Year 08 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033271