IgE-mediated Milk Allergy Clinical Trial
Official title:
Efficacy of the "Milk Ladder" Intervention in the Development of Tolerance and the Recognition of B Cell Epitopes in Babies Who Are Allergic to Cow's Milk Proteins
Food allergies have become a relevant health problem in westernized societies, particularly,
with children. Cow's milk (CM), along with hen's eggs, are the most common foods eliciting
allergic reactions in children under 4 years of age. The main objective of this intervention
study is to evaluate the safety and efficacy of the intervention known as "The Milk Ladder"
in the development of tolerance by children with CM allergies. This will be compared to an
historical cohort (CoALE), which investigated the natural history of this allergy.
Additionally, the ability of informative epitopes will be evaluated for their potential to
predict tolerance and their correlation against clinical variables.
The "Milk Ladder" will be evaluated within a prospective cohort of CM allergic children. This
intervention is enacted through the introduction of meals cooked with progressively
increasing amounts of cow's milk into the participant's diet. The primary outcome will be the
development of tolerance which will be evaluated through a double-blind placebo-controlled
food challenge. IgE and IgG4 epitopes will be described using a peptide microarray
immunoassay. Quality of life will be determined by administering the FAQLQ-PF
disease-specific questionnaire. Finally, within a subgroup of study participants, the ability
of different peptides to activate basophils will be analyzed, and CM T cell epitopes will be
studied by means of T-cell proliferation and cytokine production assays.
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