UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	effect of probiotics in low birth weight infant
Title of the study (Brief title)	probiotics in low birth weight infant
Region	Japan

Condition
Condition	low birth weight infant
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to clarify the impact of IgA secretion on probiotics in low birth weight infant
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	measurement of IgA and IgE in serum, and sIgA in stool at birth, 1month 2 month and 6month
Key secondary outcomes	measurement of IgG and IgM in serum in 1month 2 month and 6month

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 -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	viable Bifidobacterium for six months
Interventions/Control_2	heat treated Bifidobacterium for six months
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 months-old <=
Age-upper limit	6 months-old >
Gender	Male and Female
Key inclusion criteria	Low birth weight infant (1500g-2500g)
Key exclusion criteria	severe congenital anomaly
Target sample size	90

Research contact person
Name of lead principal investigator	Shigeki Koshida
Organization	Shiga University of Medical Science
Division name	Department of Community Perinatal Medicine
Address	Tsukinowa cho, Seta, Ohtsu, Shiga
TEL	077-548-2447
Email	koshida@belle.shiga-med.ac.jp

Public contact
Name of contact person	Shigeki Koshida
Organization	Shiga University of Medical Science
Division name	Department of Community Perinatal Medicine
Address	Tsukinowa cho, Seta, Ohtsu, Shiga
TEL	077-548-2447
Homepage URL
Email	koshida@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga University of Medical Science
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	Shiga University of Medical Science
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 04 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 02 Month 01 Day
Anticipated trial start date	2013 Year 03 Month 01 Day
Last follow-up date	2015 Year 04 Month 01 Day
Date of closure to data entry	2015 Year 12 Month 31 Day
Date trial data considered complete	2016 Year 12 Month 31 Day
Date analysis concluded	2017 Year 12 Month 31 Day

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

Management information
Registered date	2016 Year 01 Month 11 Day
Last modified on	2016 Year 04 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011657