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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomised, Double-blinded, Placebo-controlled, Parallel Study, to Assess the Effect of a Probiotic on the Incidence, Duration and Severity of Upper Respiratory Tract Infections in Healthy Children

Conditions
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Upper Respiratory Tract Infections, Upper Resp Tract Infection

Intervention / Treatment
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* Dietary Supplement: Probiotic
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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). 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. Taking a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Has an active gastrointestinal disorder or previous gastrointestinal surgery (appendicectomy allowed). 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 a history of such diseases. Planned extensive travel (for >1 month) during the study duration. Parent/guardian who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study. Participants may not be receiving treatment involving experimental drugs. If the Participant has been in a recent experimental trial/study, these must have been completed not less than 60 days prior to this study. Any Participant who is the child of an employee of the study site or an Atlantia Clinical Trials employee or their close family member or a member of their household.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: study consists of 2 arms, intervention and placebo.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>Arm receiving investigational product (probiotic) | Dietary Supplement: Probiotic<br>* Single strain probiotic in the form of a sachet with a daily dose of 3E+9 Colony Forming Unit (CFU) per day for 26 weeks.<br>|
| Placebo Comparator: Placebo<br>Arm receiving placebo | Dietary Supplement: Placebo<br>* Matching placebo in the form of a sachet once daily for 26 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of 26 week consumption of probiotic on the total number of days that, otherwise healthy, children suffer from upper respiratory tract infection (URTI) | Presence of an URTI defined by a score of >2 on the Jackson Cold Scale (maximum score 3) where a lower score means better outcomes compared to baseline | Entire follow up period (total of 180 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of 26 week consumption of probiotic on the number of children reporting at least one URTI | The presence of an URTI defined by a score of >2 on the Jackson Cold Scale (maximum score 3) where a lower score means better outcomes compared to baseline | Day 0, Day 90, Day 180 | 
| Effect of 26 week consumption of probiotic on the average duration of URTIs reported by participants | Duration of URTI measured through the WURSS-K questionnaire (Maximum score 42) where a lower score means better outcomes compared to baseline | Day 0, Day 90, Day 180 | 
| Effect of 26 week consumption of probiotic on the severity of URTI-related symptoms reported by participants | Severity of URTI measured through the WURSS-K questionnaire (Maximum score 42) where a lower score means better outcomes compared to baseline | Day 0, Day 90, Day 180 | 
| Effect of 26 week consumption of probiotic on the total number of reported missed days of school/childcare due to illness | Recorded through the WURSS-K questionnaire (Maximum score 42) where a lower score means better outcomes compared to baseline | Day 0, Day 90, Day 180 | 
| Effect of 26 week consumption of probiotic on the reported incidence of antibiotic use | Recorded through the WURSS-K questionnaire (Maximum score 42) where a lower score means better outcomes compared to baseline | Day 0, Day 90, Day 180 | 
| Effect of 26 week consumption of probiotic on Salivary Immunoglobulin A levels (IgA) (mg/dL) | Measured via saliva sample | Day 0, Day 180 | 
| Effect of 26 week consumption of probiotic on the incidence of gastrointestinal infections | Recorded through the WURSS-K questionnaire (Maximum score 42) where a lower score means better outcomes compared to baseline | Day 0, Day 90, Day 180 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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probiotic, microbiome