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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024221
Receipt No. R000027594
Scientific Title An impact of probiotics on respiratory infection in late preterm infants: Association between intestinal and nasopharyngeal microbiota in late preterm infants
Date of disclosure of the study information 2016/10/10
Last modified on 2019/04/02

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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
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
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/ctr_e/ctr_view.cgi?recptno=R000027594

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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