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Clinical Trials in Spain / NCT06976775
Recruiting Phase 2/3

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

NCT06976775 · tracked via the Priya Life Science Spain tracker
Sponsor
Pablo Rodríguez del Rio
Phase
Phase 2/3
Started
2025-06-03
Last updated
2026-02-18

Condition(s) studied

Food Allergy in ChildrenMilk AllergyEgg Allergy

Investigational drug(s) / intervention(s)

"Rush" regimen"Conventional" regimen →

"Rush" regimen: The "rush" regimen consists of the administration of several incremental doses daily, every day, over the first week of the Induction Phase (Part 1)

"Conventional" regimen: The "conventional" regimen consists of the administration of only one incremental dose every 2 weeks, throughout all the Induction Phase (Part 1)

Study summary

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

Eligibility

Sex
ALL
Min age
6 Years
Max age
16 Years
Healthy volunteers
No
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 Esophagitis, non-IgE mediated allergy, having started SCIT 3 months before, or SLIT one week before. Pregnancy

Primary outcome measure(s)

  • Number of adverse events with an oFASS5 severity ≥2 occurred until Induction Phase (Part 1) completion at the hospital setting per subject in both groups, rush vs conventional — Throughout the Induction Phase (Part 1), 1 week up to 7 months
  • Proportion of subjects completing the Induction Phase (Part 1) in both groups (rush vs conventional) at the end of study (7 months of treatment) — End of study (7 months of treatment)

Trial sites (1)

FacilityCityRegionStatus
Hospital Infantil Universitario Niño Jesús. Avenida de Menéndez Pelayo, número 65 Madrid Spain Recruiting

Other trials for the same condition

Tolerance Results and Immune Mechanisms in Cow´s Milk and/or Hen´s Egg Allergic Children Following Natural Evolution or Oral Immunotherapy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06976775 on ClinicalTrials.gov ↗ ← All trials in Spain