Status:
COMPLETED
Hypoallergenicity of a New Formula in Subjects With Cow's Milk Allergy
Lead Sponsor:
Federico II University
Conditions:
Allergy
Cow's Milk Allergy
Eligibility:
All Genders
6-36 years
Phase:
NA
Brief Summary
Cow's milk protein allergy (CMA) is an immune-mediated reaction which can either be antibody-driven (IgE-mediated) or cell-mediated (non-IgE-mediated) or mixed, and elicits reactions which are reprodu...
Detailed Description
This study is a randomized, double-blind, controlled, crossover study that will be performed at a tertiary center for pediatric allergy: the Pediatric Allergy Program of the Department of Translationa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 22 2024
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT06134466
Start Date
February 13 2024
End Date
July 22 2024
Last Update
August 14 2024
Active Locations (1)
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1
Department of Traslational Medical Science - University of Naples Federico II
Naples, Italy, 80131