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

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age6-16
SponsorPablo Rodríguez del Rio

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

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Pablo Rodríguez del Rio

Lead sponsor

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Sponsor institution