Children Immune Functions(2)

Study Overview
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Brief Summary
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To investigate the effect of milk-based formulas on infections and immune functions in healthy children.

Detailed Description
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Particular attention was paid to the role played by nutrition in supporting the gut ecosystem, balancing microbiota and promoting health status. In that respect, the beneficial effects of probiotics were demonstrated for different infectious diseases, GII and URI. The beneficial effect of probiotics for treatment of symptomatic diarrhea was clearly documented.

Official Title
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A Randomized, Double-blind, Placebo-controlled Study to Investigate the Effect of Milk-based Formulas on Infections and Immune Functions in Healthy Children

Conditions
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Diarrhea, Upper Respiratory Infections

Intervention / Treatment
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* Dietary Supplement: Milk with Bifidobacteria
* Dietary Supplement: Milk with non replicating lactobacilli
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parents written and signed informed consent for participation in the study. Healthy children aged 1 to 3 years that are no more breastfed. Go to a selected nursery and / or pediatrician. Parents must have a phone at home or a cellular phone to call the paediatrician. No consumption of commercial products containing probiotics or prebiotics during the 3 weeks before and during the study period. Parents are able to give their children, twice daily, 2 milk servings on a 5 months period. Children not being intensive consumers of regular yoghurts Exclusion Criteria: Rotavirus and flu vaccines administration within the last 3 months prior to V1 (baseline visit). Used antibiotics within the last 30 days prior to V1 (baseline visit). Congenital or chronic disease. Any kind of immunodeficiency or allergy, milk protein allergy or lactose intolerance. Significant illness within the two weeks prior to start of the study or any active systemic infection or medical condition that may require treatment or therapeutic intervention during the study.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 3 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Milk with Bifidobacteria<br>duration of the treatment is 5 months | Dietary Supplement: Milk with Bifidobacteria<br>* A total of 36g (4 spoons) of powder milk per serving are diluted in 220 ml of water. Two servings per day are consumed orally, corresponding to 72g per day.<br>|
| Active Comparator: Milk with non replicating lactobacilli<br>duration of the treatment is 5 months | Dietary Supplement: Milk with non replicating lactobacilli<br>* A total of 36g (4 spoons) of powder milk per serving are diluted in 220 ml of water. Two servings per day are consumed orally, corresponding to 72g per day.<br>|
| Placebo Comparator: Semi skimmed milk<br>duration of the treatment is 5 months | Dietary Supplement: placebo<br>* A total of 36g (4 spoons) of powder milk per serving are diluted in 220 ml of water. Two servings per day are consumed orally, corresponding to 72g per day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days with diarrhea |  | during the 5 months of follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of episodes of Upper Respiratory Infections |  | 5 months | 
| Duration of episodes of Upper Respiratory Infections |  | 5 months | 
| Severity of episodes of Upper Respiratory Infections |  | 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diarrhea, Children, Lactobacilli