A double-blind randomised controlled trial of the heat-inactivated Pediococcus acidilactici K15 in preterm infant to prevent viral respiratory tract infection after NICU discharge.

A double-blind randomised controlled trial of the heat-inactivated Pediococcus acidilactici K15 in preterm infant to prevent viral respiratory tract infection after NICU discharge. - The heat-inactivated Pediococcus acidilactici K15 in preterm infant trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000033758

Enrollment

Registered

2018-09-01

Start date

2019-02-01

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

Pediococcus acidilactici K15 4.5mg(100mg included Dextrin),once a day, 12months Dextrin,100mg, once a day, 12months

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The preterm infants born at less than 35 weeks and graduated in NICU or GCU in our hospital

Exclusion criteria

Exclusion criteria: 1)Patients with a precious allergy to Lactic acid bacteria or soy beans. 2)Patients with congenital heart disease, severe respiratory disease, chromosomal abnormality, and primary immunodeficiency disease. 3)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 incidence of respiratory infection which were diagnosed by physician. The severity of respiratory disturbance measured by necessities of hospitalization, oxygenation, and mechanical ventilation during respiratory infection. The incidence of respiratory syncytial virus (RSV) infection which were diagnosed by physician. The severity of respiratory disturbance measured by necessities of hospitalization, oxygenation, and mechanical ventilation during RSV infection. Serum IgG,IgA and IgM levels before and after intervention. The adverse events associated with K15.	—

Measure

Time frame

The incidence of respiratory infection which were diagnosed by physician. The severity of respiratory disturbance measured by necessities of hospitalization, oxygenation, and mechanical ventilation during respiratory infection. The incidence of respiratory syncytial virus (RSV) infection which were diagnosed by physician. The severity of respiratory disturbance measured by necessities of hospitalization, oxygenation, and mechanical ventilation during RSV infection. Serum IgG,IgA and IgM levels before and after intervention. The adverse events associated with K15.

—

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