UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomised controlled trial of the heat-killed Pediococcus acidilactici K15 in preschool children to prevent viral respiratory tract infection
Title of the study (Brief title)	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	Naoki Shimojo
Organization	Chiba University School of Medicine
Division name	Department of Pediatrics
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	Haruka Hishiki
Organization	Chiba University Hospital
Division name	Department of Pediatrics
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

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000027703