Free Amino Acid-based Formula to Treat Children Cow's Milk Protein Allergy

Study Overview
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Brief Summary
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It is a study to assess the tolerance to a new commercially available infant formula in children affected by Cow's Milk Allergy.

Detailed Description
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In the present study, the children will be followed-up during the treatment with the new formula for Cow's Milk Allergy. They will have monthly doctor's appointment, when the weight, height and symptoms will be evaluated, by a questionnaire and a physical examination.

Official Title
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Tolerability to a New Free Amino Acid-based Formula in Children With Cow's Milk Protein Allergy

Conditions
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Cow's Milk Allergy

Intervention / Treatment
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* Dietary Supplement: Amix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children with cow's milk allergy Exclusion Criteria: Children without cow's milk allergy

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 5 Years

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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amix<br>Dietary supplement. The formula is based in free amino-acid to treat children with cow's milk allergy. The children should have a minimum consumption of 400 mL, daily. | Dietary Supplement: Amix<br>* Treat the children with cow's milk allergy for 5 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study to assess the allergic symptoms, using a questionnaire. | The allergic symptoms were assessed every month, by using a questionnaire. The parents, during the medical appointment, answered yes or no according to the presented symptoms: cutaneous (atopic dermatitis and urticaria), gastrointestinal (vomiting, diarrhea constipation and bloody stools ) and respiratory. At the end of the study the children were evaluated if they tolerated the formula, it was observed by the symptoms remission. | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight assessment, using a digital infant scale | Every medical appointment the doctor measured the weight, by using a digital infant scale. The values were plotted in the software WHO Anthro. A curve weight/age was obtained and the children's weight were compared to the standard population's weight, by the z-score. | 5 months | 
| Height assessment, using an infantometer | Every medical appointment the doctor measured the height by using a digital infant scale. The values were plotted in the software Anthro. A curve height/age was obtained and the children's height were compared to the standard population's height, by the z-score. | 5 months | 
| Head circumference, using an infant tape measure | Every medical appointment the doctor measured the head circumference by using a infant tape measure. The values were plotted in the software Anthro. A curve head circumference/age was obtained and the children's head circumference were compared to the standard population's head circumference, by the z-score. | 5 months |