Effect of Therapy With Aminoacid Based Formula Versus Hydrolyzed Whey Proteins in Children With Cow's Milk Allergy

Study Overview
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Brief Summary
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Cow's milk allergy is an immunologically mediated adverse reaction to milk proteins. In industrialized countries there is an incidence of 2-3% in children younger than 2 years. Cow's milk allergy may present with different clinical pictures and symptoms often nonspecific. Among the most common are certainly food refusal and failure to thrive until frameworks frank malnutrition. It was also noted that the cow's milk allergy can have a negative impact on the quality of life of the patient and his family. The treatment of this condition provides the setting of a diet that is free of the allergen to the base of the adverse reaction. There are some types of formulas for the treatment of this condition. The formulas based on amino acids are currently used in all cases non-responsive to treatment with the above formulas or in all those characterized by severe allergic reactions. Being made from amino acids such formulas are by definition non-allergenic. They have also proven to ensure a rapid resolution of symptoms favoring a resumption of growth, nutritional status, as well as lead to a rapid improvement in the quality of life of the patient and his family. However, the studies currently available to us concerning the effects of nutritional formulas based on amino acids affect short observation periods (usually less than 6 months) and were directed to a comparison only with hydrolysates of whey protein or casein and not with healthy subjects. To date thus lack consistent data on the nutritional effects in the medium to long term.

Official Title
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Effect of Therapy With Aminoacid Based Formula Versus Hydrolyzed Whey Proteins in Children With Cow's Milk Allergy

Conditions
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Cow's Milk Allergy

Intervention / Treatment
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* Dietary Supplement: Aminoacid based formula
* Dietary Supplement: Hydrolyzed whey formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: subjects with diagnosis of cow's milk allergy Exclusion Criteria: age <5 months age >12 months other concomitant chronic diseases malformations other food allergies

Ages Eligible for Study
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Minimum Age: 5 Months
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Amino acid based formula<br> | Dietary Supplement: Aminoacid based formula<br>* Formula based on aminoacid<br>|
| Whey protein formula<br> | Dietary Supplement: Hydrolyzed whey formula<br>* Formula based on hydrolyzed whey protein<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of z-score weight at 12 months |  | after 12 months of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of body mass index at 12 months |  | after 12 months of intervention |