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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
Lallemand Health Solutions
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Respiratory Tract Infections focused on measuring Frequent respiratory infection, pediatrics, probiotics

Eligibility Criteria

3 Years - 10 Years (Child)All SexesAccepts 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.

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

    First Posted
    August 20, 2020
    Last Updated
    August 20, 2020
    Sponsor
    Lallemand Health Solutions
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    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

    Learn more about this trial

    ProbioKid as Prevention Among Kids With Frequent URTI

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