A Growth and Hypoallergenicity Study of a New Formula for Infants With Cow Milk Allergy (CMA)

Inclusion Criteria:

1. Subjects aged from birth to 8 months old with documented allergy to cow milk protein are eligible to enter the study. Subjects with other IgE or non IgE mediated allergies to food in addition to milk protein (e.g. multiple food allergy or an eosinophilic disorder) are also eligible to enter the study. However all subjects must have a confirmed allergy to milk confirmed by one of the following criteria, within two months prior to the baseline visit:

   • Positive double-blind placebo controlled food challenge with cow milk
   • A confirmed history of acute severe reaction after isolated accidental ingestion with a positive test result for IgE antibody
   • Confirmed history of a reaction to cow milk protein with CM-specific IgE of >15kU/L for children over two years and > 5kU/L for children under two years.
   • Confirmed clinical history of a reaction to cow milk protein with a positive skin prick test with a resulting wheal diameter greater or equal to 3mm.
   • No confirmed clinical history of a reaction to cow milk protein subjects with a positive skin prick test with a resulting wheal diameter greater or equal to 8mm for children over 2 years and greater or equal to 6mm for children under 2 years.
   • For children with an Allergic Eosinophilic Gastroenteritis (AEG), documentation of eosinophilic infiltration and resolution of symptoms on a diet that restricted cow milk (and other foods) with reoccurrence after re-administration of cow milk.
2. Written informed consent / ability to give informed consent.
3. These subjects are expected to consume a minimum intake of test formula to ensure an average daily intake, which provides at least 50% of their daily energy requirements,

Exclusion Criteria:

All subjects

1. Infants <5lb 8oz at birth
2. Infants < 37 weeks gestation
3. Infants with severe concurrent illness or major congenital malformations
4. Suspected or documented systemic or congenital infections (e.g. human immunodeficiency virus)
5. Unable to adhere to protocol instructions due to non compliance of parent or caregiver
6. Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
7. Participation in any other studies involving investigational products concomitantly or within twenty eight days prior to entry into the study
8. An infant of any personnel connected with the study
9. Infants whose parent/caregiver is younger than the legal age of consent
10. For these subjects the dietary consumption of other sources of prebiotics or probiotics is prohibited two weeks prior to inclusion in the study and during the study period.
11. These subjects must not have received systemic antibiotics in the previous two weeks prior to entry into the study.