Infections, Respiratory Tract
Conditions
Keywords
Children, Respiratory Tract Infections, Prevention
Brief summary
The purpose of this study is to assess the potential of probiotics in prevention of respiratory tract infections and their complications in children
Interventions
DIETARY_SUPPLEMENTL. acidophilus DDS-1, B. lactis UABLA-12
1 g of probiotic will be reconstituted in 25-50 ml tepid water, juice or age specific baby food and immediately fed once a day (5 billion CFU/daily) for 2-weeks trial period or to the end of acute respiratory infection depending on whatever is longer.
DIETARY_SUPPLEMENTPlacebo
1 g in 25-50 ml of tepid water or juice fed once a day for 2-weeks trial period or to the end of acute respiratory infection depending on whatever is longer.
Sponsors
Lviv National Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 3-12 yrs * At least one episode of respiratory tract infection in the previous epidemiological season * Direct telephone access available * Informed consent signed
Exclusion criteria
* Vaccination against the influenza * Chronic adeno-tonsillar pathology * Recurrent otitis * Sinusitis * Respiratory allergy * Acute or chronic intestinal disease with diarrhea and/or malabsorption syndrome * Lactose intolerance * Functional or organic constipation * Down syndrome * Congenital or acquired heart disease * Cerebral palsy * Any chronic hepatic, renal, metabolic, or immune system disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of respiratory tract infection episodes in a child | 1 month | An episode will be defined as display of fever, cough, rhinitis, and sore throat or combination thereof for longer than 48 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of respiratory tract infection | 21 days | a product of daily CARIFS times the duration of the disease |
| Complications of respiratory tract infections | 21 days | Percent of otitis, sinusitis, bronchitis, pneumonia cases |
| Antibiotic prescriptions | 21 days | Percent |
| Hospitalization rate | 21 days | Number of hospitalizations |
| Number of unscheduled doctor visits | 21 days | — |
| Duration of respiratory tract infection | 21 days | Time to CARIFS (Canadian Acute Respiratory Illness and Flu Scale) value 0 |
| Number of workdays missed by parents | 21 days | — |
| Time to resolution of individual CARIFS item | 21 | Days to the correspondent CARIFS item 0 |
| 25% and 50% decrease in the CARIFS score | 21day | 25% and 50% decrease in the CARIFS score |
| Percent and duration of the use of over-the-counter medications | 21day | Percent and duration of the use of over-the-counter medications |
| Number of days daycare/school missed | 21 days | — |
Countries
Ukraine
Outcome results
None listed