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:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-24 @ 4:36 PM
NCT ID:
NCT06134466
Eligibility Criteria:
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 the enrolment
* Stable clinical condition and free from any symptoms possibly related to CMA for at least four weeks prior to study enrollment
* Observing a strict cow's milk elimination diet for at least 4 weeks prior to study enrollment and until the completion of the study
* Parent(s) or legal guardian agrees not to enroll infant or child in another interventional clinical study while participating in this study
* Written informed consent obtained from at least one parent (or legally acceptable representative \[LAR\], if applicable)
* Infant or child's parent(s) / LAR is of legal age of majority, must have parental authority, must understand the informed consent form and other study documents, and are 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 major congenital anomalies (based on medical history and/or commonly performed diagnostic criteria).
* Major gastrointestinal disease/abnormalities (other than CMA).
* Other allergies.
* Immunodeficiency.
* Antihistamine use (excluding eye drops) within 7 days prior to the food challenge or oral 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 the judgement of the Investigator, would make the infant or child inappropriate for entry into the study.
* Currently participating or having participated in another interventional clinical study within 4 weeks prior to enrollment.
* Use of systemic immunomodulatory treatment
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
36 Months
Study:
NCT06134466
Study Brief:
Protocol Section:
NCT06134466