UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety and Effect of Bifidobacterium breve M-16V Supplementation to sick infants.
Title of the study (Brief title)	Safety and Effect of Bifidobacterium breve M-16V.
Region	Asia(except Japan)

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

Objectives
Narrative objectives1	To make sure the safety that there is no occurrence of adverse events and to prove its effectiveness during administration of bifidobacterium breve M-16V to sick infants in neonatal care unit of NMCHC.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	A significant increase is not observed in the incidence of adverse events in the two groups of comparison administration group and non-administration group.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	The NCU doctors instruct to administer Bifidobacteria breve (M-16V) to the registered infants.
Interventions/Control_2	Control(non-adiministration) group
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	0 days-old <=
Age-upper limit	28 days-old >=
Gender	Male and Female
Key inclusion criteria	All the sick infants who are hospitalized in NCU amongthe newborn infants born in NMCHC.
Key exclusion criteria	the infants who already have caused gastrointestinal bleeding etc. and are considered to be unsuitable for administration of bifidobacterium into the stomach
Target sample size	300

Research contact person
Name of lead principal investigator	Shinichi Hosokawa
Organization	National Center for Global Health and Medicine
Division name	Pediatrics
Address	Toyama 1-21-1, Shinjuku, Tokyo, Japan
TEL	03-3202-7181
Email	shosokaw@hosp.ncgm.go.jp

Public contact
Name of contact person	Shinichi Hosokawa
Organization	National Center for Global Health and Medicine
Division name	Pediatrics
Address	Toyama 1-21-1, Shinjuku, Tokyo, Japan
TEL	03-3202-7181
Homepage URL
Email	shosokaw@hosp.ncgm.go.jp

Sponsor
Institute	National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization	National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	National Maternal and Child Health Centre
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	2014 Year 12 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 12 Month 01 Day
Anticipated trial start date	2014 Year 12 Month 01 Day
Last follow-up date	2015 Year 12 Month 01 Day
Date of closure to data entry	2015 Year 12 Month 01 Day
Date trial data considered complete	2015 Year 12 Month 01 Day
Date analysis concluded	2015 Year 12 Month 01 Day

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

Management information
Registered date	2014 Year 11 Month 23 Day
Last modified on	2017 Year 05 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018317