Probiotics in Respiratory Tract Infections in Children

Lviv National Medical University242 enrolled

Overview

The purpose of this study is to assess the potential of probiotics in prevention of respiratory tract infections and their complications in children

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

242

Conditions

Infections, Respiratory Tract

Interventions

L. acidophilus DDS-1, B. lactis UABLA-12DIETARY_SUPPLEMENT

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.

PlaceboDIETARY_SUPPLEMENT

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.

Eligibility

Sex: ALLMin age: 3 YearsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Lviv City Children Hospital

Lviv, Lviv Oblast, Ukraine

Outcomes

Primary Outcomes

Incidence of respiratory tract infection episodes in a child

An episode will be defined as display of fever, cough, rhinitis, and sore throat or combination thereof for longer than 48 hours

Time frame: 1 month

Secondary Outcomes

Duration of respiratory tract infection

Time to CARIFS (Canadian Acute Respiratory Illness and Flu Scale) value 0

Time frame: 21 days

Severity of respiratory tract infection

a product of daily CARIFS times the duration of the disease

Time frame: 21 days

Complications of respiratory tract infections

Percent of otitis, sinusitis, bronchitis, pneumonia cases

Time frame: 21 days

Antibiotic prescriptions

Percent

Time frame: 21 days

Hospitalization rate

Number of hospitalizations

Time frame: 21 days

Number of unscheduled doctor visits

Time frame: 21 days

Number of days daycare/school missed

Time frame: 21 days

Number of workdays missed by parents

Time frame: 21 days

Time to resolution of individual CARIFS item

Data from ClinicalTrials.gov

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