Status:
RECRUITING
Comparison Between a Rush and a Conventional Oral Immunotherapy Protocol to Treat Cow's Milk and Hen´s Egg Allergy. CompITO Study
Lead Sponsor:
Pablo Rodríguez del Rio
Conditions:
Food Allergy in Children
Milk Allergy
Eligibility:
All Genders
6-16 years
Phase:
PHASE2
PHASE3
Brief Summary
This study investigates the efficacy and safety of two different OIT schemes to treat milk and egg allergic children
Detailed Description
Food immunotherapy, especially oral immunotherapy (OIT), is now a standard treatment option for patients allergic to cow´s milk, hen´s egg or peanuts. While peanut OIT has drawn considerable attention...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06976775
Start Date
June 3 2025
End Date
April 30 2027
Last Update
July 10 2025
Active Locations (1)
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1
Hospital Infantil Universitario Niño Jesús. Avenida de Menéndez Pelayo, número 65
Madrid, Spain, 28009