Respiratory Tract Infections
Conditions
Keywords
Frequent respiratory infection, pediatrics, probiotics
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTProbioKid®
Probiokid formulation includes three probiotic strains and fructooligosaccharides.
OTHERPragmatic comparator
Standard of care as usual without a preventive intervention
Sponsors
Lallemand Health Solutions
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
3 Years to 10 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and duration of URTI and related complications | 6 months prior to enrollment, and 6 months follow-up | Difference between group in the change \[ follow-up - baseline\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Monthly incidence of URTI | 6 months after the intervention | Comparison of monthly incidence of URTI between the two groups during follow-up |
| Monthly number of visits to a specialized physician | 6 months after the intervention | Comparison of monthly number of visits to a specialized physician between the two groups during follow-up |
| Resistance index | 6 months prior to enrollment and 6 months after intervention | Comparison of change in resistance index between the two groups |
| Individual complication diagnosed (number of cases) | 6 months prior to enrollment and 6 months after intervention | Comparison of the number of complications diagnosed between the two groups |
| Number of antibiotics prescriptions | 6 months prior to enrollment and 6 months after intervention | Comparison of the number of antibiotic courses prescribed between the two groups during follow-up |
Outcome results
None listed