ProbioKid as Prevention Among Kids With Frequent URTI

Study Overview
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Brief Summary
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This study was designed to evaluate the preventive efficacy of a 6-week prophylactic administration of Probiokid® on the incidence of respiratory infections and related complications in frequently sick children.

Detailed Description
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The microbiota is very important for the development of the immune system in children. Lactic acid bacteria, such as Lactobacillus and Bifidobacterium, are usually administered as probiotics (defined as live microorganisms that, when administered in adequate amounts, confer a health benefit on the host). Some probiotics were shown to sustain the development of immune competency in newborns, as well as to modulate the adaptive immune response and response to infections. For example, previous research suggests that probiotics decrease the incidence of upper respiratory tract infection (URTI). Probiokid® is a commercially-available formulation that consist of probiotics (Lactobacillus helveticus, Bifidobacterium infantis, Bifidobacterium bifidum) and fructooligosaccharides. This formulation has been shown to decrease the rate of respiratory infection in children supplemented for 3 to 9 months. Therefore the aim of this clinical trial is to assess the efficacy of Probiokid® supplemented for 6 weeks on the prevention of URTI and related complications among children (aged 3 to 10 years-old) that frequently suffer of acute respiratory infections. In addition, the impact of a prophylactic intervention with Probiokid® on the number of physician visits and antibiotic courses prescribed is assessed.

Official Title
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Experience of Using ProbioKid for Children That Often Get Sick as a Prevention for Acute Respiratory Diseases

Conditions
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Respiratory Tract Infections

Intervention / Treatment
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* Dietary Supplement: ProbioKid®
* Other: Pragmatic comparator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of children from 3 to 10 years, High frequency of acute respiratory tract infections, characterized by a resistance index more than 0.33 (i.e. ARIs more often than once every 3 months). Absence of other medications that affect the immune system in the treatment regimen (except for antibiotics, as per the care provider's judgment). Exclusion Criteria: • Chronic pathological conditions.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 10 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>Children in this arm were given ProbioKid®; one capsule daily, for 6 weeks. | Dietary Supplement: ProbioKid®<br>* Probiokid formulation includes three probiotic strains and fructooligosaccharides.<br>|
| Other: Pragmatic arm<br>Children in this arm received standard of care as usual without a preventive intervention | Other: Pragmatic comparator<br>* Standard of care as usual without a preventive intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and duration of URTI and related complications | Difference between group in the change [ follow-up - baseline] | 6 months prior to enrollment, and 6 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monthly incidence of URTI | Comparison of monthly incidence of URTI between the two groups during follow-up | 6 months after the intervention | 
| Monthly number of visits to a specialized physician | Comparison of monthly number of visits to a specialized physician between the two groups during follow-up | 6 months after the intervention | 
| Resistance index | Comparison of change in resistance index between the two groups | 6 months prior to enrollment and 6 months after intervention | 
| Individual complication diagnosed (number of cases) | Comparison of the number of complications diagnosed between the two groups | 6 months prior to enrollment and 6 months after intervention | 
| Number of antibiotics prescriptions | Comparison of the number of antibiotic courses prescribed between the two groups during follow-up | 6 months prior to enrollment and 6 months after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Frequent respiratory infection, pediatrics, probiotics