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Comparison Between a Rush and a Conventional Oral Immunotherapy Protocol to Treat Cow's Milk and Hen´s Egg Allergy. CompITO Study

RecruitingPhase 2, Phase 3Ages 6 Years - 16 YearsAllPablo Rodríguez del Rio
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In plain words

What the trial is, and whether it could suit you

This study investigates the efficacy and safety of two different OIT schemes to treat milk and egg allergic children

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 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) Exclusion Criteria: * 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) * Other exclusion criteria: uncontrolled asthma, FEV1\<70%, severe atopic dermatitis, Eosinophilic Esophagitis, non-IgE mediated allergy, having started SCIT 3 months before, or SLIT one week before. Pregnancy
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What it tests

  • "Rush" regimen
  • "Conventional" regimen
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Where

1 site
Hospital Infantil Universitario Niño Jesús. Avenida de Menéndez Pelayo, número 65
Madrid, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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