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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
114
Meals containing Milk and Milk
Hospital Clinico San Carlos
Madrid, Spain
RECRUITINGNumber of participants that develop tolerance to milk after the 'Milk Ladder' intervention
Tolerance assessment: participants who successfully pass a double-blind placebo-controlled oral food challenge without experiencing any limiting symptom
Time frame: 12 months
Number of participants experiencing any adverse reaction
Number of participants experiencing any adverse reaction to milk-containing foods along the intervention assessed by Medical Dictionary for Regulatory Activities (MedDRA), version in place at the end of the study.
Time frame: 12 months
Change in antigen-specific IgE and IgG4 epitopes repertoire
Serum specific inmunnoglobulin levels using a milk peptide microarray immunoassay
Time frame: 6 and 18 months
Quality of life
Change in quality of life total score during the intervention, assessed by the disease-specific questionnaire 'Food Allergy Quality of Life Questionnaire - Parent Form'
Time frame: 6 and 18 months
Potential T-cell epitopes
Identification of potential T-cell epitopes in serum assessed by a T lymphocyte proliferation assay and cytokine secretion
Time frame: 12 months
Ability of the milk allergenic peptides to activate basophils
In vitro determination of basophil activation upon antigen stimulation
Time frame: 12 months
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