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OpenTrials
Completed

NCT Number: NCT04525040

ProbioKid as Prevention Among Kids With Frequent URTI

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.

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Key information

Age range

3 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ProbioKid®

Dietary Supplement

Probiokid formulation includes three probiotic strains and fructooligosaccharides.

Pragmatic comparator

Other

Standard of care as usual without a preventive intervention

Primary outcomes

  1. Number and duration of URTI and related complications

    Time frame: 6 months prior to enrollment, and 6 months follow-up

    Difference between group in the change [ follow-up - baseline]

Secondary outcomes

  1. Monthly incidence of URTI

    Time frame: 6 months after the intervention

    Comparison of monthly incidence of URTI between the two groups during follow-up

  2. Monthly number of visits to a specialized physician

    Time frame: 6 months after the intervention

    Comparison of monthly number of visits to a specialized physician between the two groups during follow-up

  3. Resistance index

    Time frame: 6 months prior to enrollment and 6 months after intervention

    Comparison of change in resistance index between the two groups

  4. Individual complication diagnosed (number of cases)

    Time frame: 6 months prior to enrollment and 6 months after intervention

    Comparison of the number of complications diagnosed between the two groups

  5. Number of antibiotics prescriptions

    Time frame: 6 months prior to enrollment and 6 months after intervention

    Comparison of the number of antibiotic courses prescribed between the two groups during follow-up

Sponsors and collaborators

Lead sponsor

Lallemand Health Solutions

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 25, 2020
Registry last updated
Aug 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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