Back to resultsThe Efficacy of a Probiotic Product on Acute Upper Respiratory Tract Infections (Common Cold) in Healthy Children
Primary Purpose
Acute Upper Respiratory Tract Infections (Common Cold)
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Probi Defendum
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Acute Upper Respiratory Tract Infections (Common Cold)
Eligibility Criteria
Inclusion Criteria:
- Parents / legal guardians signed written informed consent to participate in the study.
- Healthy children (male and female) aged 3 to 7 years old (inclusive) at enrollment.
- Children attending day care center or school.
- No consumption of commercial products containing probiotics during the whole study period.
- Children not being intensive consumers of regular yoghurts (no more than one 125 g serving per day).
- Ability of the parents / legal guardians (in the Investigator's opinion) to comprehend the full nature and purpose of the study.
- 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.
- Flu vaccine administration within the last 3 months prior to enrollment.
- Use of antibiotics within the last 30 days prior to enrollment.
- Acute infection or fever at enrollment.
- Any congenital or chronic disease that in the opinion of the investigator would adversely affect the results of the study.
- Any kind of immunodeficiency or allergy (including known food allergy).
- Subjects with known hypersensitivity or allergy to any component of the study products.
- 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.
- Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study.
Sites / Locations
- AO L. Sacco
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Probi Defendum
Placebo
Arm Description
Dietary supplement (tablet) with probiotics
Dietary supplement (tablet) without probiotics
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of common cold episodes
Duration of common cold episodes
Incidence of common cold episodes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02640352
Brief Title
The Efficacy of a Probiotic Product on Acute Upper Respiratory Tract Infections (Common Cold) in Healthy Children
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
September 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Probi AB
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Upper Respiratory Tract Infections (Common Cold)
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
550 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Probi Defendum
Arm Type
Active Comparator
Arm Description
Dietary supplement (tablet) with probiotics
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Dietary supplement (tablet) without probiotics
Intervention Type
Dietary Supplement
Intervention Name(s)
Probi Defendum
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Number of common cold episodes
Time Frame
12 weeks
Title
Duration of common cold episodes
Time Frame
12 weeks
Title
Incidence of common cold episodes
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Parents / legal guardians signed written informed consent to participate in the study.
Healthy children (male and female) aged 3 to 7 years old (inclusive) at enrollment.
Children attending day care center or school.
No consumption of commercial products containing probiotics during the whole study period.
Children not being intensive consumers of regular yoghurts (no more than one 125 g serving per day).
Ability of the parents / legal guardians (in the Investigator's opinion) to comprehend the full nature and purpose of the study.
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.
Flu vaccine administration within the last 3 months prior to enrollment.
Use of antibiotics within the last 30 days prior to enrollment.
Acute infection or fever at enrollment.
Any congenital or chronic disease that in the opinion of the investigator would adversely affect the results of the study.
Any kind of immunodeficiency or allergy (including known food allergy).
Subjects with known hypersensitivity or allergy to any component of the study products.
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.
Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study.
Facility Information:
Facility Name
AO L. Sacco
City
Milano
ZIP/Postal Code
20157
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Efficacy of a Probiotic Product on Acute Upper Respiratory Tract Infections (Common Cold) in Healthy Children
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