Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07484035
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Months
Maximum Age:
5 Months
Study:
NCT07484035
Study Brief:
Protocol Section:
NCT07484035