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OpenTrials
Completed

NCT Number: NCT02640352

The Efficacy 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.

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Key information

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AO L. Sacco

Milan, 20157, Italy

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Probi Defendum

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  1. 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 outcomes

  1. Number of common cold episodes

    Time frame: 12 weeks

  2. Duration of common cold episodes

    Time frame: 12 weeks

  3. Incidence of common cold episodes

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Probi AB

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Dec 28, 2015
Registry last updated
Oct 17, 2018

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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