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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04525040
Other study ID # ProbioKid study
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 14, 2016
Est. completion date June 25, 2017

Study information

Verified date July 2020
Source Lallemand Health Solutions
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date June 25, 2017
Est. primary completion date June 25, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 10 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
ProbioKid®
Probiokid formulation includes three probiotic strains and fructooligosaccharides.
Other:
Pragmatic comparator
Standard of care as usual without a preventive intervention

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Lallemand Health Solutions

Outcome

Type Measure Description Time frame Safety issue
Primary Number and duration of URTI and related complications Difference between group in the change [ follow-up - baseline] 6 months prior to enrollment, and 6 months follow-up
Secondary Monthly incidence of URTI Comparison of monthly incidence of URTI between the two groups during follow-up 6 months after the intervention
Secondary 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 6 months after the intervention
Secondary Resistance index Comparison of change in resistance index between the two groups 6 months prior to enrollment and 6 months after intervention
Secondary Individual complication diagnosed (number of cases) Comparison of the number of complications diagnosed between the two groups 6 months prior to enrollment and 6 months after intervention
Secondary Number of antibiotics prescriptions Comparison of the number of antibiotic courses prescribed between the two groups during follow-up 6 months prior to enrollment and 6 months after intervention
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