Study to Assess Hypoallergenicity of a New Amino-acid Based Infant Formula in Children With Cow's Milk Allergy

A Multicenter, Randomized, Controlled, Cross-over Study to Assess Hypoallergenicity of a New Amino-acid Based Infant Formula in Children With Cow's Milk Allergy

This is a prospective, controlled, multi-country study to verifying the hypoallergenicity of the new amino acid-based formula in infants and children aged< 12 years with documented cow's milk protein allergy (CMPA).

Not Provided

Inclusion Criteria:

• Children with documented cow's milk allergy, confirmed by one of the following criteria, within six months prior to study start (visit 2):

  • Positive double-blind, placebo-controlled oral food challenge (DBPCFC) with cow's milk OR
  • Positive open or single-blind oral food challenge with cow's milk carried out under the supervision of a specialist in children with clear immediate reactions and a positive test for specific IgE (in serum [sIgE>0,35 KUI/L] or skin prick test [SPT ≥ 3 mm]) OR
  • Reported convincing allergic symptoms following an exposure to milk or a milk-containing food product and detectable serum milk-specific IgE or positive skin prick test

• Aged ≤12 years of age at screening.

• Expected consumption of a minimum of 250ml of study formula per day during the open challenge.

• Written informed consent from one or both parents (depending on the local legislation) or legal representative.

Exclusion Criteria:

• Children who receive breastfeeding at study enrolment.
• Had any chronic medical diseases, chromosomal or major congenital anomalies, or major gastrointestinal disease/abnormalities (other the CMPA); had immunodeficiency; antihistamine [excluding eye drops] use in 7 days prior to a food challenge or oral steroid use within 14 days prior to enrolment; unstable asthma; severe uncontrolled eczema;
• Severe anaphylactic reaction [required ≥ 2 doses of epinephrine] to milk or breast milk within the past 2 years;
• Existing illness that could interfere with formula acceptance or identification of allergic reactions.
• Investigator's uncertainty about the willingness or ability of the parents 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.