Evaluation of the Hypoallergenicity of an Extensively Hydrolyzed Formula

Evaluation of the Hypoallergenicity of a New Thickened Extensively Hydrolyzed Formula in Infants With Confirmed Cow's Milk Protein Allergy

The aim of this study is to assess the hypoallergenicity of a new thickened extensively hydrolyzed formula, in infants with confirmed cow's milk protein allergy assessed through a double blind placebo controlled food challenge, followed by a 3-month open feeding period.

Main Inclusion Criteria:

Infants:

• with cow's milk allergy confirmed by a double-blind food challenge performed in the last 2 months,
• successfully fed an eviction diet for at least 2 weeks

Main Non-inclusion Criteria:

Infants:

• fed with an extensively hydrolyzed formula with no improvement of the symptoms,
• who refused to drink an extensively hydrolyzed formula anytime prior to inclusion,
• fed a vegetable based formula
• fed an amino acid based formula or who should be fed with an amino acid based formula according to recommendations
• who had an anaphylactic reaction in the past