An Elimination Diet Using a New Amino Acid Based Formula: Immunological and Clinical Effects in Cow's Milk Allergy

Study Overview
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Brief Summary
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The purpose of this study is to evaluate whether a new version of an amino acid based formula improves tolerance to milk in cow's milk allergic infants/young children.

Detailed Description
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Infants with CMA cannot tolerate proteins contained in milk, although they are able to tolerate amino acids which are the 'building blocks' of proteins. Unlike standard infant formulas which are made from milk proteins, amino acid formulas (AAF) are made from nonallergenic aminoacids plus all the other nutrients required to support growth and development.

Official Title
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A Prospective, Double Blind Randomised Controlled Trial to Evaluate the Immunological Benefits and Clinical Effects of an Elimination Diet Using an Amino Acid Based Formula (AAF)

Conditions
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Allergy, Food Allergy

Intervention / Treatment
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* Other: Special Medical Food
* Other: Special Medical Food


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants ≤ 8 months of age Infants sensitised to cow's milk and diagnosed with IgE mediated cow's milk allergy confirmed by milk challenge or diagnosis of anaphylaxis to milk within the last 3 months Exclusion Criteria: Infants less than 2500 g at birth Infants less than 37 weeks gestation Infants with severe concurrent illness Use of anti- histamines, systemic corticosteroids, systemic antibiotics or anti-mycotic drugs, and immuno-modulatory drugs Infants consuming less than 500ml per day of their usual formula at study entry Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study

Ages Eligible for Study
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Maximum Age: 8 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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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Amino acid based formula<br>Patients will be randomised to one of two arms: Group I: receiving a new amino-acid based formula Group II: receiving a standard AAF formula | Other: Special Medical Food<br>* Comparison between a standard amino acid based formula and a new amino acid based formula. Subjects with CMA will take their randomised formula for 12 months. Following completion of the intervention (12 months), subjects will transfer to an age appropriate formula and be followed-up at 24 and 36 months. Infants should typically consume the following amounts of formula during the study > 500mls/day up to 12 months of age > 400mls/day between 12 and 18 months of age > 300mls/day over 18 months of age.<br>* Other names: Amino acid based formula, Neocate LCP;|
| Active Comparator: New amino acid based formula<br>Patients will be randomised to one of two arms: Group I: receiving a new amino-acid based formula Group II: receiving a standard AAF formula | Other: Special Medical Food<br>* Comparison between a standard amino acid based formula and a new amino acid based formula. Subjects with CMA will take their randomised formula for 12 months. Following completion of the intervention (12 months), subjects will transfer to an age appropriate formula and be followed-up at 24 and 36 months. Infants should typically consume the following amounts of formula during the study > 500mls/day up to 12 months of age > 400mls/day between 12 and 18 months of age > 300mls/day over 18 months of age.<br>* Other names: Amino acid based formula;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the development of oral tolerance in infants with IgE mediated CMA on control or test AAF. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate maturation of the GI immune system in IgE mediated CMA To confirm that the test formula is effective in the dietary management of CMA To assess frequency of other allergies |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allergy, Cow's Milk, Infants, Food Allergy