ProbioKid as Prevention Among Kids With Frequent URTI

Respiratory Tract Infections Clinical Trial

Official title:

Experience of Using ProbioKid for Children That Often Get Sick as a Prevention for Acute Respiratory Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04525040
• Other study ID #: ProbioKid study
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Respiratory Tract Infections

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