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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
56
Probiokid formulation includes three probiotic strains and fructooligosaccharides.
Standard of care as usual without a preventive intervention
Number and duration of URTI and related complications
Difference between group in the change \[ follow-up - baseline\]
Time frame: 6 months prior to enrollment, and 6 months follow-up
Monthly incidence of URTI
Comparison of monthly incidence of URTI between the two groups during follow-up
Time frame: 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
Time frame: 6 months after the intervention
Resistance index
Comparison of change in resistance index between the two groups
Time frame: 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
Time frame: 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
Time frame: 6 months prior to enrollment and 6 months after intervention
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.