The Efficacy of a Probiotic Product on Acute Upper Respiratory Tract Infections (Common Cold) in Healthy Children

A Randomized, Double Blind, Placebo-controlled Study to Investigate the Effect of a Probiotic Product on Acute Upper Respiratory Tract Infections (Common Cold) in Healthy Children

The aim of the present study is to test the efficacy of the combination of two probiotic bacteria in reducing the severity of upper respiratory tract infections (common cold) in healthy children attending day care or school. The probiotic bacteria used are Lactobacillus plantarum strain DSM 15312 and Lactobacillus paracasei DSM 13434 at a total dose of 1 x 10^9 CFU/tablet and day and will be consumed for a period of 12 weeks.

Study Overview

• Status: Completed
• Conditions: Acute Upper Respiratory Tract Infections (Common Cold)
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Probi Defendum

• Study Type: Interventional
• Enrollment (Actual): 550
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milano, Italy, 20157
    • AO L. Sacco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Parents / legal guardians signed written informed consent to participate in the study.
2. Healthy children (male and female) aged 3 to 7 years old (inclusive) at enrollment.
3. Children attending day care center or school.
4. No consumption of commercial products containing probiotics during the whole study period.
5. Children not being intensive consumers of regular yoghurts (no more than one 125 g serving per day).
6. Ability of the parents / legal guardians (in the Investigator's opinion) to comprehend the full nature and purpose of the study.
7. Parents' / legal guardians' consent to the study and willing to comply with all its procedures.

Exclusion Criteria:

Children presenting one or more of the following criteria will not be eligible to enter the study.

1. Flu vaccine administration within the last 3 months prior to enrollment.
2. Use of antibiotics within the last 30 days prior to enrollment.
3. Acute infection or fever at enrollment.
4. Any congenital or chronic disease that in the opinion of the investigator would adversely affect the results of the study.
5. Any kind of immunodeficiency or allergy (including known food allergy).
6. Subjects with known hypersensitivity or allergy to any component of the study products.
7. Significant illness within the 2 weeks prior to the enrollment or any active systemic infection or medical condition that may require treatment or therapeutic intervention during the study.
8. Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Probi Defendum; Dietary supplement (tablet) with probiotics	Dietary supplement: Probi Defendum
Placebo Comparator: Placebo; Dietary supplement (tablet) without probiotics	Dietary supplement: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Severity of acute upper respiratory tract infections (common cold), by means of the validated Canadian Acute Respiratory Illness and Flu Scale (CARIFS) questionnaire (total sum score), during 12 weeks of daily intake of either Probi Defendum® or placebo.	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of common cold episodes	12 weeks
Duration of common cold episodes	12 weeks
Incidence of common cold episodes	12 weeks

Collaborators and Investigators

• Sponsor: Probi AB

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: December 22, 2015
• First Submitted That Met QC Criteria: December 22, 2015
• First Posted (Estimate): December 28, 2015

Study Record Updates

• Last Update Posted (Actual): October 17, 2018
• Last Update Submitted That Met QC Criteria: October 16, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Disease Attributes; Picornaviridae Infections; Infections; Communicable Diseases; Respiratory Tract Infections; Common Cold
• Other Study ID Numbers: PROIMKID_15

Plan for Individual participant data (IPD)

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