Evaluation of Probiotics on Symptoms of Upper Respiratory Tract Infections

Study Overview
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Brief Summary
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The aim of the present prospective study is to investigate whether the consumption of certain probiotic strains over a six-month winter/spring season would be able to affect the incidence and duration of upper respiratory tract infections, in otherwise healthy children as well as determining whether a combination of two strains would perform differently from a single strain version.

Official Title
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Probiotics and Effects on Illness-Related Symptoms for Pre-School Age Children

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Placebo
* Dietary Supplement: Lactobacillus acidophilus NCFM
* Dietary Supplement: Combination of Lactobacillus acidophilus and Bifidobacterium lactis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged 3-5 years of normal nutritional status and health Exclusion Criteria: Contraindications to dairy products (lactose intolerance or cow's milk allergy) Indicators of inflammatory disease, intestinal disease, Crohn's disease, colitis, celiac disease Chronic cough from recurring respiratory distress-related diseases Hirschsprung's disease Cystic fibrosis Other metabolic, neurological, or anatomic alteration that predisposes participation Intake of probiotics within the last 3 weeks

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 5 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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo | Dietary Supplement: Placebo<br>* Inert excipient<br>|
| Active Comparator: Active 1<br>One probiotic strain | Dietary Supplement: Lactobacillus acidophilus NCFM<br>* 1e10 CFU/day<br>|
| Active Comparator: Active 2<br>Blend of two strains | Dietary Supplement: Combination of Lactobacillus acidophilus and Bifidobacterium lactis<br>* 1x10e10 CFU/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine if the consumption of two different probiotic strains added to milk at the point of consumption could reduce the flu-like symptoms and other symptoms of illness of preschool-age children in day care centers. |  | Daily for six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if children who consume a beverage fortified with a probiotic miss fewer days of preschool as measured by illness. |  | Six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotic, Lactobacillus, NCFM, Bifidobacterium, Healthy children