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Recruiting Phase 2, Phase 3 NCT06976775

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

Trial Parameters

Condition Food Allergy in Children
Sponsor Pablo Rodríguez del Rio
Study Type INTERVENTIONAL
Phase Phase 2, Phase 3
Enrollment 40
Sex ALL
Min Age 6 Years
Max Age 16 Years
Start Date 2025-06-03
Completion 2027-04-30
Interventions
"Rush" regimen"Conventional" regimen

Brief Summary

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

Eligibility Criteria

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

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