UMIN-CTR Clinical Trial

Basic information
Public title	An impact of probiotics on respiratory infection in late preterm infants: Association between intestinal and nasopharyngeal microbiota in late preterm infants
Acronym	An impact of probiotics on respiratory infection in late preterm infants
Scientific Title	An impact of probiotics on respiratory infection in late preterm infants: Association between intestinal and nasopharyngeal microbiota in late preterm infants
Scientific Title:Acronym	An impact of probiotics on respiratory infection in late preterm infants
Region	Japan

Condition
Condition	Late preterm infants
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate an impact of probiotics on respiratory infection in late preterm infants. We will analyze intestinal and nasopharyngeal microbiota using the next generation sequence. We propose to clarify microbiota modification with probiotics and association between the risk and/or severity of respiratory infection and microbiota.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	rate of respiratory tract infection(RTI) during the first year of life
Key secondary outcomes	(1) changes in intestinal and nasopharyngeal microbiota (2) frequency of RTI episodes during the first year of life (3) a rate of admission for RTI during the first year of life (4) a rate of admission for infection excluding RTI during the first year of life (5) severe adverse events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	In the exposure group, probiotics are given orally between day 3 and day 60 of life.
Interventions/Control_2	In the control group, placebo is given orally between day 3 and day 60 of life.
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 days-old <=
Age-upper limit	3 days-old >=
Gender	Male and Female
Key inclusion criteria	(1) premature baby born at gestational age between 34+0 and 36+6 weeks, birth weight >1700g, and admit to NICU or GCU (2) infants whose informed consent has been obtained from their guardians
Key exclusion criteria	(1) chromosome abnormalities (2) infants with diseases preventing enteral nutrition during follow-up period (3) infants inappropriate for the study judged by the principal
Target sample size	100

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Akihiko Saitoh
Organization	Niigata University Medical and Dental Hospital
Division name	Pediatrics
Zip code
Address	1-757 Asahi-machi, Chuo-ku, Niigata
TEL	025-227-2222
Email	asaitoh@med.niigata-u.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Rie Habuka
Organization	Niigata University Medical and Dental Hospital
Division name	Pediatics
Zip code
Address	1-757 Asahi-machi, Chuo-ku, Niigata
TEL	025-227-2222
Homepage URL
Email	shonike.kenkyu.niigata@gmail.com

Sponsor
Institute	Niigata University Medical and Dental Hospital
Institute
Department

Funding Source
Organization	Niigata University Medical and Dental Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 10 Month 10 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	24
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 05 Day
Date of IRB	2016 Year 04 Month 25 Day
Anticipated trial start date	2017 Year 03 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 12 Month 31 Day
Date trial data considered complete	2019 Year 12 Month 31 Day
Date analysis concluded	2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2016 Year 09 Month 29 Day
Last modified on	2019 Year 04 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027594