Probiotic S. Salivarius K12 for the Prevention of Upper Respiratory Tract Infection in Nursery-age Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this retrospective study is to assess the treatment benefits of probiotic Streptococcus salivarius K12 for the prevention of recurrent bacterial and viral infections of the pharynx, tonsils and ears in children under 3 years of age.

Detailed Description
-----------------
Recurrent bacterial and viral infections of the pharynx, tonsils and ears are a problem that can affect children of all ages. The persistence of these infections can lead to an overuse of drugs such as antibiotics, antipyretics and anti-inflammatories, with the possible consequent presence of side effects and above all an increase in antibiotic resistance, a global public health issue. In search at reducing the use of antibiotics and antivirals, there is currently a great scientific interest in probiotic therapies for the oral cavity infection. The aim of this retrospective, controlled, multicenter, non-profit study is to evaluate the efficacy and safety of the administration of Streptococcus salivarius K12 in pediatric patients attending the 1st or 2nd year of nursery school (< 3 years of age ), in the prophylaxis of the most common bacterial or viral respiratory infections, assessing the consequent reduction in the use of antibiotics, antivirals or other therapies compared to children.

Official Title
-----------------
Possible Prophylactic Role of the S. Salivarius K12 Probiotic Strain for the Upper Respiratory Tract Infection and Nursery-age Children

Conditions
-----------------
Upper Respiratory Tract Infection

Intervention / Treatment
-----------------
* Dietary Supplement: Probiotic Streptococcus salivarius K12
* Other: No probiotic supplementation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy children attending the 1st or 2nd year of nursery (under aged 3 years) Treated with probiotic Streptococcus salivarius K12 (1 billion CFU) for 90 continuous days Children not treated with probiotic Streptococcus salivarius K12 Exclusion Criteria: Children with underlying health condition

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 3 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic Streptococcus salivarius K12 Treatment Group<br>Children treated with Probiotic Streptococcus salivarius K12 Treatment for continuous 3-months | Dietary Supplement: Probiotic Streptococcus salivarius K12<br>* Oral 1 billion CFU of Probiotic Streptococcus salivarius K12<br>|
| Active Comparator: Control Group<br>Children who did not receive any probiotic treatment | Other: No probiotic supplementation<br>* Children who did not receive any probiotic supplementation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of any Gastrointestinal upset | Safety and tolerability of the probiotic treatment | 03 Months | 
| Bacterial or respiratory viral infection | Evaluation of the frequency of bacterial or respiratory viral infection | 03 Months | 
| Use of antibiotics or antivirals | Evaluation of the frequency of use of antibiotic or antiviral therapies | 03 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other pathologies | Evaluation of the frequency of incidence of other pathologies such as GI | 03 Months |