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:
2025-12-25 @ 4:45 AM
Ignite Modification Date:
2025-12-25 @ 4:45 AM
NCT ID:
NCT06664918
Eligibility Criteria:
Inclusion Criteria:
* Age between 1 and 5 years.
* Diagnosis of IgE-mediated CMPA confirmed according to ESPGHAN guidelines, by a positive OFC with CMPs. In high-risk children (i.e., with a history of anaphylaxis), diagnosis based on positive skin prick testing and/or elevated specific IgE to CMPs is sufficient.
* On a therapeutic elimination diet for at least 6 months or up to 12 months of age.12
* Eligible regardless of the risk of systemic reaction (anaphylaxis) and asthma.
* Good overall health status.
* Parents without language barriers.
* Written informed consent signed by parents.
* Good cooperation with the child's guardians.
Exclusion Criteria:
* Uncontrolled asthma, defined as the presence of shortness of breath, chest tightness, cough, and/or auscultatory changes despite treatment.
* Signs of exacerbation of a chronic disease.
* Signs of acute infectious disease (i.e., acute runny nose, cough, subfebrile fever, or fever).
* Signs of exacerbation of another allergic disease (i.e., conjunctivitis, allergic rhinitis, atopic dermatitis).
* Anaphylaxis due to CMPs in the last 6 months.
* Used antihistamines within 3-10 days before the challenge (depending on the characteristics of the drug and the reason for use).
* Acquired tolerance to baked CMPs or higher steps of the milk ladder.
* Use of immunosuppressive drugs or immunotherapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
5 Years
Study:
NCT06664918
Study Brief:
Protocol Section:
NCT06664918