ProbioKid as Prevention Among Kids With Frequent URTI

NCT ID: NCT04525040

Last Updated: 2020-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-14
• Study Completion Date: 2017-06-25

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.

Conditions

Respiratory Tract Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention arm

Children in this arm were given ProbioKid®; one capsule daily, for 6 weeks.

Group Type: EXPERIMENTAL

ProbioKid®

Intervention Type: DIETARY_SUPPLEMENT

Probiokid formulation includes three probiotic strains and fructooligosaccharides.

Pragmatic arm

Children in this arm received standard of care as usual without a preventive intervention

Group Type: OTHER

Pragmatic comparator

Intervention Type: OTHER

Standard of care as usual without a preventive intervention

Interventions

ProbioKid®

Probiokid formulation includes three probiotic strains and fructooligosaccharides.

Intervention Type: DIETARY_SUPPLEMENT

Pragmatic comparator

Standard of care as usual without a preventive intervention

Intervention Type: OTHER

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lallemand Health Solutions

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yu V. Marushko, MD

Role: PRINCIPAL_INVESTIGATOR

Bogomolets National Medical University (Kiev, Ukraine)

Other Identifiers

ProbioKid study

Identifier Type: -

Identifier Source: org_study_id