A Study to Assess the Effect of a Probiotic on Upper Respiratory Tract Infections in Healthy Children

Last updated: April 8, 2025
Sponsor: The Archer-Daniels-Midland Company
Overall Status: Completed

Phase

N/A

Condition

Respiratory Syncytial Virus (Rsv) Infection

Treatment

Placebo

Probiotic

Clinical Study ID

NCT05577065
CTB2022TN108
AFCRO158
  • Ages 2-8
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This study evaluates the efficacy of a single strain probiotic on the incidence, duration and severity of upper respiratory tract infections in healthy, school-age children.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Have a parent/guardian able to give written informed consent.

  2. If ≥7 years, be able to give written informed assent.

  3. Healthy children aged 2 - 8 years old.

  4. In general good health, as determined by the investigator.

  5. Attending a registered childcare provider or school.

  6. Willing to consume the study product daily for the duration of the study.

Exclusion

Exclusion Criteria:

  1. Has URTI symptoms at the time of randomisation.

  2. Are <2 or ≥9 years old.

  3. Diagnosed with concomitant chronic infections, chronic systemic diseases, autoimmunediseases (e.g. asthma - generally only formally diagnosed after child is 6 years),immunodeficiency, metabolic diseases, chronic respiratory tract diseases includingrespiratory allergies and cystic fibrosis or congenital cardiac defects.

  4. Has a family household member that smokes cigarettes in the home.

  5. Has taken antibiotics within the previous 2 weeks prior to randomisation.

  6. Has taken probiotic supplements within the previous 2 weeks prior to randomisation

  7. Daily intake of immune stimulating products, including but not limited to echinacea,vitamin C and zinc in the 2 weeks before randomisation (multivitamins allowed).

  8. Has any significant health conditions that would prevent them from fulfilling thestudy requirements, put the Participant at risk or would confound the interpretationof the study results as judged by the investigator on the basis of medical historyand routine laboratory test results.

  9. Taking a medication that the investigator believes would interfere with theobjectives of the study or pose a safety risk or confound the interpretation of thestudy results.

  10. Has an active gastrointestinal disorder or previous gastrointestinal surgery (appendicectomy allowed).

  11. Has a gastrointestinal or chronic infective disease (i.e., coeliac disease,diarrhoea, Crohn's disease, ulcerative colitis, irritable bowel syndrome,diverticulosis, stomach or duodenal ulcers, hepatitis, HIV, cancer, etc.), or with ahistory of such diseases.

  12. Planned extensive travel (for >1 month) during the study duration.

  13. Parent/guardian who, in the opinion of the investigator, are considered to be poorattendees or unlikely for any reason to be able to comply with the study.

  14. Participants may not be receiving treatment involving experimental drugs. If theParticipant has been in a recent experimental trial/study, these must have beencompleted not less than 60 days prior to this study.

  15. Any Participant who is the child of an employee of the study site or an AtlantiaClinical Trials employee or their close family member or a member of theirhousehold.

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Placebo
Phase:
Study Start date:
January 30, 2023
Estimated Completion Date:
March 13, 2024

Connect with a study center

  • Atlantia Food Clinical Trials

    Cork, T23 R50R
    Ireland

    Site Not Available

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