NIPH Clinical Trials Search

A randomised controlled trial of the heat-killed Pediococcus acidilactici K15 in preschool children to prevent viral respiratory tract infection

Basic Information

Recruitment status	Complete: follow-up complete
Health condition(s) or Problem(s) studied	Prevention of viral respiratory tract infection
Date of first enrollment	2016/10/19
Target sample size	200
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	heat-killed Pediococcus acidilactici K15 (10mg/day, 4months) Dextrin (10mg/day, 4months)

Outcome(s)

Primary Outcome

The number of febrile days during the exam period

Secondary Outcome

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

Key inclusion & exclusion criteria

Age minimum	3years-old
Age maximum	6years-old
Gender	Male and Female
Include criteria
Exclude 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.