UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Collection of side effects associated with the administration of bifidobacteria with the aim of fixing of the intestinal flora of pathological newborn.
Title of the study (Brief title)	Collection of side effects associated with the administration of bifidobacteria.
Region	Japan

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

Objectives
Narrative objectives1	data collecting
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	no side effect
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	administration of bifidobacteria
Interventions/Control_2
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	sick baby
Key exclusion criteria	intestinal bleeding
Target sample size	200

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

Public contact
Name of contact person	Keiji Goishi
Organization	National Center for Global Health and Medicine
Division name	Pediatrics
Address	Toyama 1-21-1 Shinjuku
TEL	03-3202-7181
Homepage URL
Email	kgoishi@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
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 07 Month 26 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 03 Month 16 Day
Anticipated trial start date	2015 Year 03 Month 16 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 26 Day
Last modified on	2017 Year 12 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026891