Hypoallergenicity of an extensively hydrolyzed whey protein infant formula in children with cow's milk allergy.

Cow’s milk allergy is caused by an abnormal reaction of a child’s immune system to milk proteins and is characterized by rapid appearance of symptoms, such as wheezing, vomiting, diarrhea, abdominal pain, and exacerbation of eczema, after consumption of cow’s milk proteins.



Treatment of cow’s milk allergy in children therefore means total avoidance of cow’s milk and use of special developed so−called ‘hypoallergenic’ milk formulas. In the ‘hypoallergenic' milk formulas the milk proteins are broken down into small pieces, so the immune system does not recognize the proteins as dangerous anymore and no allergic reaction is provoked.



Even hypoallergenic formulas might contain some cow’s milk proteins that were not broken down sufficiently. The remaining bigger proteins might still provoke allergic reactions in children with cow’s milk allergy. Therefore hypoallergenic formulas first need to be tested in research studies before they can be generally used to treat children with cow’s milk allergy. Such studies must demonstrate that the formula is tolerated by a substantial percentage of children with cow’s milk allergy and does not cause allergic responses.



In the current study a new hypoallergenic milk formula will be tested in children aged 0 to 24 months with cow's milk allergy. For the participants, the study will last a minimum of 6 weeks and consists of several hospital visits and assessments, including a double−blind, placebo−controlled food challenge. Furthermore, the participant's parents should complete diaries regarding their child's food intake (including study product) and gastro−intestinal/allergic symptoms.

The formula will be tolerated by at least 90% of the children with cow's milk allergy with a confidence interval of 95%.

Screening will take at least one hospital visit. As from the start of phase A, the study will take 3 hospital visits and 3 phone calls.

Duration of intervention:
Phase A: one day, twice;
Phase B: two weeks.

Intervention group: extensively hydrolyzed whey protein based infant formula.

Control group: amio acid-based infant formula.