Actively Recruiting

Phase 2
Phase 3
Age: 6Years - 16Years
All Genders
ID06976775

Comparative Analysis Between Two Oral Immunotherapy Schemes in Cow´s Milk and/or Hen´s Egg Allergic Children to Improve Treatment Efficiency and Identify Response Biomarkers. CompITO Study

Led by Pablo Rodríguez del Rio · Updated on 2026-02-18

40

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Brief Title

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

Who Can Participate

Age: 6Years - 16Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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)
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hospital Infantil Universitario Niño Jesús. Avenida de Menéndez Pelayo, número 65

Madrid, Spain, 28009

Actively Recruiting

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Research Team

D

Dr. Pablo Rodríguez del Río

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

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

Itziar Eusebio-Cartagena, Rodrigo Jiménez-Saiz, Vanesa Esteban...

https://pubmed.ncbi.nlm.nih.gov/41168926