ProbioKid as Prevention Among Kids With Frequent URTI

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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Tract Infections
• Intervention / Treatment: Dietary supplement: ProbioKid®; Other: Pragmatic comparator

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 10 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention arm; Children in this arm were given ProbioKid®; one capsule daily, for 6 weeks.	Dietary supplement: ProbioKid®; Probiokid formulation includes three probiotic strains and fructooligosaccharides.
OTHER: Pragmatic arm; Children in this arm received standard of care as usual without a preventive intervention	Other: Pragmatic comparator; Standard of care as usual without a preventive intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monthly incidence of URTI	Comparison of monthly incidence of URTI between the two groups during follow-up	6 months after the intervention
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
Resistance index	Comparison of change in resistance index between the two groups	6 months prior to enrollment and 6 months after intervention
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
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

Collaborators and Investigators

• Sponsor: Lallemand Health Solutions
• Investigators: Principal Investigator: Yu V. Marushko, MD, Bogomolets National Medical University (Kiev, Ukraine)

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 14, 2016
• Primary Completion (ACTUAL): June 25, 2017
• Study Completion (ACTUAL): June 25, 2017

Study Registration Dates

• First Submitted: August 20, 2020
• First Submitted That Met QC Criteria: August 20, 2020
• First Posted (ACTUAL): August 25, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 25, 2020
• Last Update Submitted That Met QC Criteria: August 20, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: pediatrics; probiotics; Frequent respiratory infection
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Respiratory Tract Infections
• Other Study ID Numbers: ProbioKid study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No