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

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)

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.

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.

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