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

Recruiting now · Phase 2/Phase 3

Conditions studied: Food Allergy in Children, Milk Allergy, Egg Allergy

In brief

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

Key facts

Study ID: NCT06976775
Run by: Pablo Rodríguez del Rio
People needed: 40
Starts: 2025-06-03
Expected to finish: 2027-04-30
Last updated by the study team: 2026-02-18

Who can join

Age: 6 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

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

Where it is running

Hospital Infantil Universitario Niño Jesús. Avenida de Menéndez Pelayo, número 65 — Madrid, Spain (enrolling)

Full record on ClinicalTrials.gov

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