Evaluation of Extensively Hydrolyzed Formula for Cow's Milk Protein Allergy in Infants

Study start date: March 5, 2026

Inclusion Criteria: Subjects must meet all of the following criteria to be eligible for participation: * Born at 37-42 weeks gestation with birth weight 2500-4000 g * Aged 0 to 5 months at enrollment * Diagnosed with mild-to-moderate CMPA by a physician based on the Nowak-Wegrzyn (2019) diagnostic criteria, meeting any of the following prior to enrollment: (a) Typical allergic symptoms + sensitization markers * Symptoms: Clear allergic reactions (e.g., urticaria, vomiting, dyspnea) following exposure to cow's milk or dairy products * Evidence of sensitization (any one of the following): * Serum cow's milk-specific IgE \>0.7 kIU/L * Serum cow's milk-specific IgE \>0.35 kUA/L * Positive skin prick test (wheal diameter ≥5 mm) (b) High-threshold serum specific IgE * Infants aged \<1 year: Cow's milk-specific IgE ≥5 kIU/L (c) Strongly positive SPT * SPT wheal diameter ≥10 mm (regardless of age) (d) Positive oral food challenge under medical supervision * Dietary elimination for at least 2 weeks, followed by OFC provoking immediate allergic reactions (e) Physician-confirmed diagnosis * Physician-confirmed diagnosis of CMPA supported by medical records dated within 2 weeks * Written informed consent voluntarily signed by at least one parent or legal guardian * Parents or legal guardians able to understand the informed consent form and other study documents, and willing and able to comply with study requirements * Parents or legal guardians agree not to enroll the infant in any other clinical studies during the trial period Exclusion Criteria: Subjects meeting any of the following criteria are not eligible for participation: * Recent onset of allergic symptoms due to causes other than cow's milk protein (including other food allergens, inhalant allergies, contact allergies, drug allergies, insect bite allergies, etc.) * Use of any extensively hydrolyzed formula (eHF) or amino acid formula (AAF) for the treatment of cow's milk protein allergy within 1 month prior to enrollment * Known intolerance to ingredients in the study formula (e.g., lactose intolerance) * Severe cow's milk protein allergy requiring treatment with amino acid formula (AAF) * Presence of severe congenital diseases or malformations, major organ dysfunction, genetic or metabolic disorders, or infectious diseases of the gastrointestinal tract or other sites * Growth retardation due to causes other than cow's milk protein allergy, or other significant medical conditions that, in the opinion of the investigator, may affect growth and/or development * Need for specialized diets or feeding methods (e.g., amino acid formula, metabolic disorder formula, or tube feeding) * Complementary foods already introduced * Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in the study * Concurrent participation in another clinical study