Growth and Plasma Amino Acids in Infants With CMPA and Treated With a Newly Innovated Amino Acid Formula

Study Overview
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Brief Summary
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The purpose of this study is to determine growth and protein status of infants with cow's milk protein allergy and treated with a newly innovated amino acid formula compared to those with a commercial amino acid formula.

Detailed Description
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Severe cases of cow's milk protein allergy are treated with the amino acid formula. The amino acid formula is composed of essential and non-essential amino acids, vegetable oils with or without MCT oil, and glucose polymer from various carbohydrate sources. Such formula is also fortified by minerals, trace elements,and vitamins.

Official Title
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Growth and Plasma Amino Acid Levels in Infants With Cow's Milk Protein Allergy and Treated With a Newly Innovated Amino Acid Formula (NAAF) Compared to a Commercial Amino Acid Formula (AAF)

Conditions
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Cow Milk Allergy

Intervention / Treatment
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* Dietary Supplement: Comparison of treatment with different amino acid formulas


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Singleton Clinical diagnosis of cow's milk protein allergy Exclusion Criteria: Other diseases

Ages Eligible for Study
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Minimum Age: 1 Week
Maximum Age: 6 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Amino acid formula<br>Comparison of growth between subjects who are fed with a newly innovated amino acid formula (NAAF) and who are fed with either Neocate or nutramigen AA. | Dietary Supplement: Comparison of treatment with different amino acid formulas<br>* Growth and amino acid status of a newly innovated amino acid formula (NAAF) and a commercial amino acid formula (AAF)<br>* Other names: a newly innovated amino acid formula;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth and protein status | compare body weight, length, head circumference, triceps skin fold thickness, mid-arm circumference, and arm muscle area between NAAF and AAF groups compare plasma amino acids, serum albumin, blood urea nitrogen, and creatinine between NAAF and AAF groups | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth | compare weight, length, head circumference, triceps skin fold thickness, mid-arm circumference, and arm muscle area between either NAAF group or AAF group and normal infants fed with either breast milk or infant formula. compare plasma amino acids between either NAAF group or AAF group and normal published data | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cow milk allergy, amino acid formula