About this trial
This study investigates the efficacy and safety of two different OIT schemes to treat milk and egg allergic children
Eligibility criteria
Qualifiers
Patients 6 to 16 years old
sIgE levels to milk 0.35 to 35kUA/L for milk allergic subjects and egg 0.35 to 35kUA/L for egg allergic subjects
Entry DBPCFC discrete milk eliciting dose (ED)≥ 22.2mg of milk protein and discrete egg ED≥18.5mg of egg protein, that are the population-based reference values for the ED20
Having a mild to moderate food allergy severity per DEFASE score (<13 points)
Disqualifiers
sIgE levels to milk >35kUA/L for milk allergic subjects and egg > 35kUA/L for milk allergic subjects
Entry DBPCFC discrete milk ED<22.2mg of milk protein or discrete egg ED<18.5mg of egg protein
Entry DBPCFC discrete ED for milk>2112mg of milk protein (cumulative amount of 4193,7mg of milk protein) and egg discrete ED>1560mg of egg protein (cumulative amount of 3110.8mg of egg protein)
Having severe food allergy per DEFASE score (≥13 points)
Trial design
Treatments tested in this trial
- "Rush" regimen
- "Conventional" regimen
Treatment groups
Sponsors and collaborators
Pablo Rodríguez del Rio
Lead sponsor
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Sponsor institution