Probiotics in Respiratory Tract Infections in Children

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

Official Title
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Role of Probiotics in Prevention of Respiratory Tract Infections in Preschool and Primary School Children

Conditions
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Infections, Respiratory Tract

Intervention / Treatment
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* Dietary Supplement: L. acidophilus DDS-1, B. lactis UABLA-12
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>1 g of rice maltodextrin will be reconstituted in 25-50 ml of tepid water or juice and immediately fed once a day for 2-weeks trial period or to the end of acute respiratory infection depending on whatever is longer. | Dietary Supplement: Placebo<br>* 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.<br>* Other names: Rice maltodextrin;|
| Experimental: Probiotic<br>powder of L. acidophilus DDS-1, B. lactis UABLA-12, 50 mg of fructooligosaccharide 1 g of probiotic will be reconstituted in 25-50 ml tepid water or juice 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 Supplement: L. acidophilus DDS-1, B. lactis UABLA-12<br>* 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.<br>* Other names: DDS-Junior;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of respiratory tract infection | Time to CARIFS (Canadian Acute Respiratory Illness and Flu Scale) value 0 | 21 days | 
| Severity of respiratory tract infection | a product of daily CARIFS times the duration of the disease | 21 days | 
| Complications of respiratory tract infections | Percent of otitis, sinusitis, bronchitis, pneumonia cases | 21 days | 
| Antibiotic prescriptions | Percent | 21 days | 
| Hospitalization rate | Number of hospitalizations | 21 days | 
| Number of unscheduled doctor visits |  | 21 days | 
| Number of days daycare/school missed |  | 21 days | 
| Number of workdays missed by parents |  | 21 days | 
| Time to resolution of individual CARIFS item | Days to the correspondent CARIFS item 0 | 21 | 
| 25% and 50% decrease in the CARIFS score | 25% and 50% decrease in the CARIFS score | 21day | 
| Percent and duration of the use of over-the-counter medications | Percent and duration of the use of over-the-counter medications | 21day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Children, Respiratory Tract Infections, Prevention