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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000024432

Enrollment

200

Registered

2016-10-18

Start date

2016-10-19

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of viral respiratory tract infection

Interventions

heat-killed Pediococcus acidilactici K15 (10mg/day, 4months) Dextrin (10mg/day, 4months)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy 3-6 year old children attending kindergarten

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
The number of febrile days during the exam period	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactHaruka Hishiki

Chiba University Hospital Department of Pediatrics

hishikih@faculty.chiba-u.jp043-222-7171

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026