Efficacy and Tolerance of a Follow-On Formula Fed to Children From 36-48 Months of Age

Study Overview
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Brief Summary
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The purpose is to determine if the consumption of study product has an effect on acute respiratory infections and/or diarrheal disease.

Conditions
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Acute Respiratory Infection, Diarrheal Disease

Intervention / Treatment
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* Dietary Supplement: Cow's milk
* Dietary Supplement: Follow-On Formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Child 36-48 months of age Child is currently attending a daycare and has attended for 6 months or less Has consumed cow's milk or a cow's milk-based beverage during the 48 hours prior to randomization Signed informed consent Exclusion Criteria: Child who received any food product or supplement containing probiotics or prebiotics in the 15 days prior to randomization Child with allergy to gluten or serious concurrent illness that will interfere in the general management of the child Child with diarrhea or acute respiratory infection during the 48 hours prior to randomization Child's z-score of weight for height < -3 according to World Health Organization criteria

Ages Eligible for Study
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Minimum Age: 36 Months
Maximum Age: 48 Months

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Cow's Milk<br>Powdered whole cow's milk | Dietary Supplement: Cow's milk<br>* Powdered whole cow's milk<br>|
| Experimental: Follow-On Formula<br>Powdered Follow-On Formula with added long-chain Polyunsaturated fatty acid, prebiotics, and polysaccharide | Dietary Supplement: Follow-On Formula<br>* Powdered Follow-On Formula with added long-chain Polyunsaturated fatty acid, prebiotics, and polysaccharide<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute respiratory infections and diarrheal disease |  | 28 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Allergic manifestations |  | 28 weeks | 
| Systemic antibiotic use |  | 28 weeks | 
| Duration of acute respiratory infection and diarrheal disease |  | 28 weeks | 
| Changes in stool patterns |  | Baseline and 28 weeks | 
| Fecal immune markers |  | Baseline and 28 weeks | 
| Serum Ferritin status |  | Baseline and 28 weeks | 
| Incidence of stool parasites |  | Baseline and 28 weeks | 
| Growth |  | 28 weeks | 
| Adverse events | The incidence of any adverse event for each participant | 28 weeks | 
| Acceptance of study product | Acceptance of study product based on quantity consumed. | 28 weeks | 
| Serum immune markers |  | Baseline and 28 weeks | 
| Serum zinc status |  | Baseline and 28 weeks |