ProbioKid as Prevention Among Kids With Frequent URTI

Lallemand

Status: Completed

Conditions: Respiratory Tract Infections

Treatments: Dietary Supplement: ProbioKid®; Other: Pragmatic comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT04525040

ProbioKid study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 3 to 10 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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56 participants in 2 patient groups

Intervention arm

Experimental group

Description:

Children in this arm were given ProbioKid®; one capsule daily, for 6 weeks.

Treatment:

Dietary Supplement: ProbioKid®

Pragmatic arm

Other group

Description:

Children in this arm received standard of care as usual without a preventive intervention

Treatment:

Other: Pragmatic comparator