Probiotics in Respiratory Tract Infections in Children
Phase 2
Completed
- Conditions
- Infections, Respiratory Tract
- Registration Number
- NCT01510938
- Lead Sponsor
- Lviv National Medical University
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 242
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 Number of unscheduled doctor visits 21 days Number of days daycare/school missed 21 days Time to resolution of individual CARIFS item 21 Days to the correspondent CARIFS item 0
Percent and duration of the use of over-the-counter medications 21day Percent and duration of the use of over-the-counter medications
Complications of respiratory tract infections 21 days Percent of otitis, sinusitis, bronchitis, pneumonia cases
25% and 50% decrease in the CARIFS score 21day 25% and 50% decrease in the CARIFS score
Severity of respiratory tract infection 21 days a product of daily CARIFS times the duration of the disease
Hospitalization rate 21 days Number of hospitalizations
Antibiotic prescriptions 21 days Percent
Trial Locations
- Locations (1)
Lviv City Children Hospital
🇺🇦Lviv, Ukraine
Lviv City Children Hospital🇺🇦Lviv, Ukraine