ProbioKid as Prevention Among Kids With Frequent URTI
Primary Purpose
Respiratory Tract Infections
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ProbioKid®
Pragmatic comparator
Sponsored by
About this trial
This is an interventional prevention trial for Respiratory Tract Infections focused on measuring Frequent respiratory infection, pediatrics, probiotics
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention arm
Pragmatic arm
Arm Description
Children in this arm were given ProbioKid®; one capsule daily, for 6 weeks.
Children in this arm received standard of care as usual without a preventive intervention
Outcomes
Primary Outcome Measures
Number and duration of URTI and related complications
Difference between group in the change [ follow-up - baseline]
Secondary Outcome Measures
Monthly incidence of URTI
Comparison of monthly incidence of URTI between the two groups during follow-up
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
Resistance index
Comparison of change in resistance index between the two groups
Individual complication diagnosed (number of cases)
Comparison of the number of complications diagnosed between the two groups
Number of antibiotics prescriptions
Comparison of the number of antibiotic courses prescribed between the two groups during follow-up
Full Information
NCT ID
NCT04525040
First Posted
August 20, 2020
Last Updated
August 20, 2020
Sponsor
Lallemand Health Solutions
1. Study Identification
Unique Protocol Identification Number
NCT04525040
Brief Title
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
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 14, 2016 (Actual)
Primary Completion Date
June 25, 2017 (Actual)
Study Completion Date
June 25, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lallemand Health Solutions
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Tract Infections
Keywords
Frequent respiratory infection, pediatrics, probiotics
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
Children in this arm were given ProbioKid®; one capsule daily, for 6 weeks.
Arm Title
Pragmatic arm
Arm Type
Other
Arm Description
Children in this arm received standard of care as usual without a preventive intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
ProbioKid®
Intervention Description
Probiokid formulation includes three probiotic strains and fructooligosaccharides.
Intervention Type
Other
Intervention Name(s)
Pragmatic comparator
Intervention Description
Standard of care as usual without a preventive intervention
Primary Outcome Measure Information:
Title
Number and duration of URTI and related complications
Description
Difference between group in the change [ follow-up - baseline]
Time Frame
6 months prior to enrollment, and 6 months follow-up
Secondary Outcome Measure Information:
Title
Monthly incidence of URTI
Description
Comparison of monthly incidence of URTI between the two groups during follow-up
Time Frame
6 months after the intervention
Title
Monthly number of visits to a specialized physician
Description
Comparison of monthly number of visits to a specialized physician between the two groups during follow-up
Time Frame
6 months after the intervention
Title
Resistance index
Description
Comparison of change in resistance index between the two groups
Time Frame
6 months prior to enrollment and 6 months after intervention
Title
Individual complication diagnosed (number of cases)
Description
Comparison of the number of complications diagnosed between the two groups
Time Frame
6 months prior to enrollment and 6 months after intervention
Title
Number of antibiotics prescriptions
Description
Comparison of the number of antibiotic courses prescribed between the two groups during follow-up
Time Frame
6 months prior to enrollment and 6 months after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu V. Marushko, MD
Organizational Affiliation
Bogomolets National Medical University (Kiev, Ukraine)
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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ProbioKid as Prevention Among Kids With Frequent URTI
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