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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024432
Receipt No. R000027703
Scientific Title A randomised controlled trial of the heat-killed Pediococcus acidilactici K15 in preschool children to prevent viral respiratory tract infection
Date of disclosure of the study information 2016/10/18
Last modified on 2018/10/22

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Basic information
Public title A randomised controlled trial of the heat-killed Pediococcus acidilactici K15 in preschool children to prevent viral respiratory tract infection
Acronym The heat-killed Pediococcus K15 in preschool children trial
Scientific Title A randomised controlled trial of the heat-killed Pediococcus acidilactici K15 in preschool children to prevent viral respiratory tract infection
Scientific Title:Acronym The heat-killed Pediococcus K15 in preschool children trial
Region
Japan

Condition
Condition Prevention of viral respiratory tract infection
Classification by specialty
Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this research is to evaluate the effect of heat-killed Pediococcus K15 in prevention of viral respiratory tract infections for children attending preschool.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes The number of febrile days during the exam period
Key secondary outcomes The number of absent days due to common cold symptoms
The incidence of influenza which were diagnosed by physician
The duration of fever during influenza infection
Salivary influenza-specific IgA or IgG/total IgA or IgGantibody levels in samples collected before and after treatment
Metabolic Profiling of salivary samples by NMR
Side effect associated with intake of K15 (abdominal pain, exanthema etc.)
The analysis of intestinal bacterial flora in stool samples

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 Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 heat-killed Pediococcus acidilactici K15 (10mg/day, 4months)
Interventions/Control_2 Dextrin (10mg/day, 4months)
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
3 years-old <=
Age-upper limit
6 years-old >=
Gender Male and Female
Key inclusion criteria Healthy 3-6 year old children attending kindergarten
Key exclusion criteria 1)Patients with a precious allergy to Lactic acid bacteria or soy beans.
2)Patients with congenital heart disease or severe respiratory disease.
3)Patients born as premature birth newborn (fetus age was <37 weeks or body weight was <2,500g).
4)Patients who were determined as unsuitable subjects by investigators.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Shimojo
Organization Chiba University School of Medicine
Division name Department of Pediatrics
Zip code
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
Middle name
Last name Haruka Hishiki
Organization Chiba University Hospital
Division name Department of Pediatrics
Zip code
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 Chiba University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor National institute of advanced industrial science and technology
Institute for Enzyme Research, Tokushima University
Name of secondary funder(s) Kikkoman Corporation

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 千葉大学医学部附属病院(千葉県)

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 18 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 Completed
Date of protocol fixation
2016 Year 10 Month 17 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 19 Day
Last follow-up date
2017 Year 07 Month 27 Day
Date of closure to data entry
2017 Year 07 Month 28 Day
Date trial data considered complete
2017 Year 08 Month 09 Day
Date analysis concluded
2017 Year 11 Month 17 Day

Other
Other related information

Management information
Registered date
2016 Year 10 Month 17 Day
Last modified on
2018 Year 10 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027703

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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