Unique ID issued by UMIN | UMIN000024432 |
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Receipt number | 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 15:16:37 |
A randomised controlled trial of the heat-killed Pediococcus acidilactici K15 in preschool children to prevent viral respiratory tract infection
The heat-killed Pediococcus K15 in preschool children trial
A randomised controlled trial of the heat-killed Pediococcus acidilactici K15 in preschool children to prevent viral respiratory tract infection
The heat-killed Pediococcus K15 in preschool children trial
Japan |
Prevention of viral respiratory tract infection
Child |
Others
NO
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.
Safety,Efficacy
Phase II
The number of febrile days during the exam period
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
Interventional
Parallel
Randomized
Cluster
Double blind -all involved are blinded
Placebo
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
YES
Central registration
2
Prevention
Food |
heat-killed Pediococcus acidilactici K15 (10mg/day, 4months)
Dextrin (10mg/day, 4months)
3 | years-old | <= |
6 | years-old | >= |
Male and Female
Healthy 3-6 year old children attending kindergarten
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.
200
1st name | |
Middle name | |
Last name | Naoki Shimojo |
Chiba University School of Medicine
Department of Pediatrics
1-8-1 Inohana Chiba, Chuo-ku, Japan
043-222-7171
shimojo@faculty.chiba-u.jp
1st name | |
Middle name | |
Last name | Haruka Hishiki |
Chiba University Hospital
Department of Pediatrics
1-8-1 Inohana Chiba, Chuo-ku, Japan
043-222-7171
hishikih@faculty.chiba-u.jp
Chiba University
Chiba University
Other
National institute of advanced industrial science and technology
Institute for Enzyme Research, Tokushima University
Kikkoman Corporation
NO
千葉大学医学部附属病院(千葉県)
2016 | Year | 10 | Month | 18 | Day |
Unpublished
Completed
2016 | Year | 10 | Month | 17 | Day |
2016 | Year | 10 | Month | 19 | Day |
2017 | Year | 07 | Month | 27 | Day |
2017 | Year | 07 | Month | 28 | Day |
2017 | Year | 08 | Month | 09 | Day |
2017 | Year | 11 | Month | 17 | Day |
2016 | Year | 10 | Month | 17 | Day |
2018 | Year | 10 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027703
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