Study to estimate the efficacy of heat-killed Lactobacillus (K15) to privent infection in infant after discharge from NICU or GCU; double-blind, randomized controlled trial

Study to estimate the efficacy of heat-killed Lactobacillus (K15) to privent infection in infant after discharge from NICU or GCU; double-blind, randomized controlled trial - Study to estimate the efficacy of heat-killed Lactobacillus (K15) to privent infection in infant after discharge from NICU or GCU; double-blind, randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000036440

Enrollment

Registered

2019-04-08

Start date

2019-02-28

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

infants who were born within gestational age of 35 weeks or less and were treated in and discharged from NICU or GCU

Interventions

administer 4.6mg of K15 (adjusted to total 100mg with dextrin) once daily from the first outpatient visit to 12 months orally or by tube administer placebo (100mg of dextrin) once daily from the first

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) infants who were born within gestational age of 35 weeks or less and were treated in and discharged from NICU or GCU 2) Signed consent form to participate in the study was obtained from the infant's legal representative (guardian) by her/his free will after full explanation of this study

Exclusion criteria

Exclusion criteria: 1) infants who have allergy to Lactobacillus preparation or products derived from soy 2) infants who have congenital heart defect, severe respiratory disorder, chromosomal abnormality, or primary immunodeficiency 3) infants who are considered unsuitable to participate in this study by attending physician

Design outcomes

Primary

Measure	Time frame
duration of fever episodes	—

Secondary

Measure	Time frame
1. frequency of respiratory tract infection 2. severity of respiratory tract infection 3. frequency of Respiratory syncytial virus (RSV) infection diagnosed by physician 4. Severity of respiratory disorder 5. Serum IgG, IgA, IgM before and after treatment 6. side effects related to K15 administration	—

Countries

Japan

Contacts

Public ContactHiroki Takayama

Soiken Inc. Clinical Study Support Division

takayama@soi-kenkyu.com03-3295-1350

Outcome results

None listed

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