Hypoallergenicity of a New Formula in Subjects With Cow's Milk Allergy

Inclusion Criteria:

• Infants and children between 6 and 36 months of age

• Gestational age ≥ 37 weeks

• Diagnosis of CMA confirmed through a DBPCFC performed within 3 months prior to theenrolment

• Stable clinical condition and free from any symptoms possibly related to CMA for atleast four weeks prior to study enrollment

• Observing a strict cow's milk elimination diet for at least 4 weeks prior to studyenrollment and until the completion of the study

• Parent(s) or legal guardian agrees not to enroll infant or child in anotherinterventional clinical study while participating in this study

• Written informed consent obtained from at least one parent (or legally acceptablerepresentative [LAR], if applicable)

• Infant or child's parent(s) / LAR is of legal age of majority, must have parentalauthority, must understand the informed consent form and other study documents, andare willing and able to fulfill the requirements of the study protocol

Exclusion Criteria:

• History of anaphylaxis to milk

• Infant is exclusively breastfed

• Any chronic diseases (except mild-moderate atopic eczema), chromosomal or majorcongenital anomalies (based on medical history and/or commonly performed diagnosticcriteria).

• Major gastrointestinal disease/abnormalities (other than CMA).

• Other allergies.

• Immunodeficiency.

• Antihistamine use (excluding eye drops) within 7 days prior to the food challenge ororal steroid use within 14 days prior to the food challenge.

• Persistent wheeze or chronic respiratory disease.

• Severe uncontrolled eczema.

• Infant or child's parent has other medical or psychiatric condition that, in thejudgement of the Investigator, would make the infant or child inappropriate forentry into the study.

• Currently participating or having participated in another interventional clinicalstudy within 4 weeks prior to enrollment.

• Use of systemic immunomodulatory treatment