A Study to Assess the Effect of a Probiotic on Upper Respiratory Tract Infections in Healthy Chil… (NCT05577065) | Clinical Trial Compass
CompletedNot Applicable
A Study to Assess the Effect of a Probiotic on Upper Respiratory Tract Infections in Healthy Children
Ireland200 participantsStarted 2023-01-30
Plain-language 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.
Who can participate
Age range2 Years – 8 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Have a parent/guardian able to give written informed consent.
✓. If ≥7 years, be able to give written informed assent.
✓. Healthy children aged 2 - 8 years old.
✓. In general good health, as determined by the investigator.
✓. Attending a registered childcare provider or school.
✓. Willing to consume the study product daily for the duration of the study.
Exclusion criteria
✕. Has URTI symptoms at the time of randomisation.
✕. Are \<2 or ≥9 years old.
✕. Diagnosed with concomitant chronic infections, chronic systemic diseases, autoimmune diseases (e.g. asthma - generally only formally diagnosed after child is 6 years), immunodeficiency, metabolic diseases, chronic respiratory tract diseases including respiratory allergies and cystic fibrosis or congenital cardiac defects.
✕. Has a family household member that smokes cigarettes in the home.
✕. Has taken antibiotics within the previous 2 weeks prior to randomisation.
✕. Has taken probiotic supplements within the previous 2 weeks prior to randomisation
✕. Daily intake of immune stimulating products, including but not limited to echinacea, vitamin C and zinc in the 2 weeks before randomisation (multivitamins allowed).
What they're measuring
1
Effect of 26 week consumption of probiotic on the total number of days that, otherwise healthy, children suffer from upper respiratory tract infection (URTI)
Timeframe: Entire follow up period (total of 180 days)
✕. Has any significant health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results.