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

Last updated: October 16, 2018
Sponsor: Probi AB
Overall Status: Completed

Phase

N/A

Condition

Common Cold

Respiratory Syncytial Virus (Rsv) Infection

Acute Rhinitis

Treatment

N/A

Clinical Study ID

NCT02640352
PROIMKID_15
  • Ages 3-7
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 studyperiod.

  5. Children not being intensive consumers of regular yoghurts (no more than one 125 gserving per day).

  6. Ability of the parents / legal guardians (in the Investigator's opinion) to comprehendthe full nature and purpose of the study.

  7. Parents' / legal guardians' consent to the study and willing to comply with all itsprocedures.

Exclusion

Exclusion Criteria: Children presenting one or more of the following criteria will not be eligible to enter thestudy.

  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 wouldadversely 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 studyproducts.

  7. Significant illness within the 2 weeks prior to the enrollment or any active systemicinfection or medical condition that may require treatment or therapeutic interventionduring the study.

  8. Currently participating or having participated in another clinical trial during thelast 4 weeks prior to the beginning of this study.

Study Design

Total Participants: 550
Study Start date:
December 01, 2015
Estimated Completion Date:
September 30, 2018

Connect with a study center

  • AO L. Sacco

    Milano, 20157
    Italy

    Site Not Available

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