UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024221 |
|---|---|
| Receipt number | 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 10:04:40 |
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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
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
shonike.kenkyu.niigata@gmail.com
Sponsor or person
Institute
Niigata University Medical and Dental Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027594
