UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033758 |
|---|---|
| Receipt number | R000038367 |
| Scientific Title | A double-blind randomised controlled trial of the heat-inactivated Pediococcus acidilactici K15 in preterm infant to prevent viral respiratory tract infection after NICU discharge. |
| Date of disclosure of the study information | 2018/09/01 |
| Last modified on | 2022/12/25 22:21:21 |
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Basic information
Public title
A double-blind randomised controlled trial of the heat-inactivated Pediococcus acidilactici K15 in preterm infant to prevent viral respiratory tract infection after NICU discharge.
Acronym
The heat-inactivated Pediococcus acidilactici K15 in preterm infant trial
Scientific Title
A double-blind randomised controlled trial of the heat-inactivated Pediococcus acidilactici K15 in preterm infant to prevent viral respiratory tract infection after NICU discharge.
Scientific Title:Acronym
The heat-inactivated Pediococcus acidilactici K15 in preterm infant trial
Region
| Japan |
Condition
Condition
Prevention of viral respiratory tract infection
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this research is to evaluate the effect of inactivated Pediococcus K15 in prevention of viral respiratory tract infections for preterm infants after NICU discharge.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The number of febrile days during the exam period
Key secondary outcomes
The incidence of respiratory infection which were diagnosed by physician. The severity of respiratory disturbance measured by necessities of hospitalization, oxygenation, and mechanical ventilation during respiratory infection. The incidence of respiratory syncytial virus (RSV) infection which were diagnosed by physician. The severity of respiratory disturbance measured by necessities of hospitalization, oxygenation, and mechanical ventilation during RSV infection. Serum IgG,IgA and IgM levels before and after intervention. The adverse events associated with K15.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Pediococcus acidilactici K15 4.5mg(100mg included Dextrin),once a day, 12months
Interventions/Control_2
Dextrin,100mg, once a day, 12months
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The preterm infants born at less than 35 weeks and graduated in NICU or GCU in our hospital
Key exclusion criteria
1)Patients with a precious allergy to Lactic acid bacteria or soy beans.
2)Patients with congenital heart disease, severe respiratory disease, chromosomal abnormality, and primary immunodeficiency disease.
3)Patients who were determined as unsuitable subjects by investigators.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Shimojo |
Organization
Chiba University School of Medicine
Division name
Department of Pediatrics
Zip code
2608670
Address
1-8-1 Inohana Chiba, Chuo-ku, Japan
TEL
043-222-7171
shimojo@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Haruka |
| Middle name | |
| Last name | Hishiki |
Organization
Chiba University Hospital
Division name
Department of Pediatrics
Zip code
2608670
Address
1-8-1 Inohana Chiba, Chuo-ku, Japan
TEL
043-222-7171
Homepage URL
hishikih@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Kikkoman Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kikkoman Corporation
Osaka Ohtani University
Osaka university
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba university School of Medicine IRB
Address
1-8-1 Inohana Chiba, Chuo-ku, Japan
Tel
043-226-2841
igaku-rinri@office.chiba-u.jp
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
千葉大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 01 | 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
41
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
| 2018 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 07 | Day |
Date analysis concluded
| 2023 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 15 | Day |
Last modified on
| 2022 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038367
