Reduction of cow’s milk protein allergy risk by using a formula with partially hydrolyzed whey protein.

In the present multi-centre study the Cow’s Milk Allergy (CMA) risk reduction of apreventive HA (Hypo Allergenic) formula is studied in a high risk (based on family history of allergies) group of infants, as compared to standard infant formula and fully breast milk fed infants, during the first 6 months of life. During this period the infants will visit the researchers every month to evaluate growth and symptoms of allergy. In a follow up study at the ages of 8 and 12 months the incidence of allergic symptoms will be monitored by questionnaires, whereas growth will be measured at the age of 12 months. This part of the study (2nd half year of life) however will be analyzed separately and is not part of the present main study.

The design of the present study is in particular based on the German Infant Nutritional Intervention Study (GINI). The read-outs of this study will be: 1) allergic/atopic manifestations (all manifestations and atopic dermatitis in particular) to show the product’s efficacy, and 2) growth (weight, length, head circumference) for safety and suitability of the product. In case of allergic/atopic manifestations, a proper diagnosis will take place.

The preventive HA formula will show on average a 40% risk-reduction for AD (54% when AD is not present in family history and 22% when AD is present in the family history) as compared to a standard formula.

2) The preventive HA will show a 30% risk reduction for total allergic manifestations, as compared to standard formula.

Monthly visits during the first half year of life, and follow up at the age of 8 and 12 months using questionnaires.

Partially hydrolyzed protein formula during the first 6 months of life. Control groups are standard infant formula and fully breast fed infants