Clinical trial NCT04525040: ProbioKid as Prevention Among Kids With Frequent URTI
Official title: Experience of Using ProbioKid for Children That Often Get Sick as a Prevention for Acute Respiratory Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Tract Infections
Keywords: Frequent respiratory infection
pediatrics
probiotics
Lead sponsor: Lallemand Health Solutions
Sponsor class: INDUSTRY
First posted: 2020-08-25
Enrollment: 56
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number and duration of URTI and related complications
timeFrame: 6 months prior to enrollment, and 6 months follow-up
Secondary outcomes:
measure: Monthly incidence of URTI
timeFrame: 6 months after the intervention
measure: Monthly number of visits to a specialized physician
timeFrame: 6 months after the intervention
measure: Resistance index
timeFrame: 6 months prior to enrollment and 6 months after intervention
measure: Individual complication diagnosed (number of cases)
timeFrame: 6 months prior to enrollment and 6 months after intervention
measure: Number of antibiotics prescriptions
timeFrame: 6 months prior to enrollment and 6 months after intervention
Other outcomes:
Locations:
Study officials:
affiliation: Bogomolets National Medical University (Kiev, Ukraine)
name: Yu V. Marushko, MD
role: PRINCIPAL_INVESTIGATOR
References: