Status:
COMPLETED
Step Down Approach in Children With Cow Milk Allergy
Lead Sponsor:
Federico II University
Conditions:
Allergy Milk
Eligibility:
All Genders
Up to 6 years
Phase:
NA
Brief Summary
Cow's milk allergy (CMA) affects up to 3% of European children. In the absence of an alternative to cow's milk, the management of CMA is based on the use of safe, affordable and nutritionally adequate...
Detailed Description
60 Immunoglobulin E-mediated CMA children, consecutively observed at tertiary Centers for Food Allergy, who will meet the inclusion criteria will be invited to participate to the study. Anamnestic, de...
Eligibility Criteria
Inclusion
- Infants aged \<6 months
- sure diagnosis of IgE-mediated CMA confirmed by positive oral food challenge for cow's milk and or blood Cow milk protein specific IgE\>0.1kiloUnits/Liter and/or Skin Prick Testing (SPT) for milk wheal size ≥ 3mm
- children receiving AAF for at least 4 weeks
- full and stable remission of CMA symptoms.
Exclusion
- Infant aged \> 6 months,
- CMP-induced anaphylaxis,
- evidence of non-IgE-mediated CMA,
- other food allergies,
- other allergic diseases,
- eosinophilic disorders of the gastrointestinal tract,
- chronic systemic diseases,
- congenital cardiac defects,
- active tuberculosis,
- autoimmune diseases,
- immunodeficiency,
- chronic inflammatory bowel diseases,
- celiac disease,
- cystic fibrosis,
- metabolic diseases,
- malignancy,
- chronic pulmonary diseases,
- malformations of the gastrointestinal and/or respiratory tract,
- administration of prebiotics or probiotics during the 4 weeks before enrolment,
- use of systemic antibiotics or anti-mycotic drugs during 4 weeks before study entry;
- investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements;
- participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03449537
Start Date
April 1 2018
End Date
December 31 2020
Last Update
February 22 2024
Active Locations (1)
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1
Department of Traslational Medical Science - University of Naples Federico II
Naples, Italy, 80131