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
Not Applicable
- Conditions
- infants who were born within gestational age of 35 weeks or less and were treated in and discharged from NICU or GC
- Registration Number
- JPRN-UMIN000036440
- Lead Sponsor
- Graduate School of Medicine, Chiba University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method duration of fever episodes
- Secondary Outcome Measures
Name Time Method 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