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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033758
Receipt No. 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 2019/04/05

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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
Email 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
Email hishikih@faculty.chiba-u.jp

Sponsor
Institute Chiba University
Institute
Department

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
Email 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
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 Enrolling by invitation
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
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 08 Month 15 Day
Last modified on
2019 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038367

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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