UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of Bifidobacterium breve (BBG-01) administration in Neonatal Intensive Care Unit cared preterm infants to gain enterobacterial flora
Title of the study (Brief title)	Effects of Bifidobacterium breve (BBG-01) administration in Neonatal Intensive Care Unit cared preterm infants
Region	Japan

Condition
Condition	Neonatal Intensive Care Unit cared preterm infants
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We will evaluate the effects of B. breve administration for early development of bifidobacteria dominated microbiota in Neonatal Intensive Care Unit cared preterm infants.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Early development of bifidobacteria dominated microbiota
Key secondary outcomes	Weight gain, diseases prevention, and infants' health

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -but assessor(s) are 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	BBG-01
Interventions/Control_2	BBG-01
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	0 days-old <=
Age-upper limit	28 days-old >=
Gender	Male and Female
Key inclusion criteria	BBG-01
Key exclusion criteria	BBG-01
Target sample size	20

Research contact person
Name of lead principal investigator	Hisamichi Tauchi
Organization	Ehime University Graduate School of Medicine
Division name	Department of Pediatrics
Address	Shitsukawa, Toon, Ehime
TEL	089-960-5320
Email	tauchi@m.ehime-u.ac.jp

Public contact
Name of contact person	Hisamichi Tauchi
Organization	Ehime University Graduate School of Medicine
Division name	Department of Pediatrics
Address	Shitsukawa, Toon, Ehime
TEL	089-960-5320
Homepage URL
Email	tauchi@m.ehime-u.ac.jp

Sponsor
Institute	Ehime University Graduate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Ehime University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 15 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 01 Month 25 Day
Anticipated trial start date	2016 Year 08 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2016 Year 07 Month 27 Day
Last modified on	2016 Year 07 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026702