Rush versus conventional oral immunotherapy for cow's milk and hen's egg allergy in children
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
This test compares a faster 'rush' oral immunotherapy schedule with a conventional slower schedule to see which better helps children aged 6–16 with milk or egg allergy tolerate those foods.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 6 Years to 16 Years |
| Sex | All |
| Sponsor | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Madrid) |
| Trial ID | NCT06976775 on ClinicalTrials.gov |
What this trial studies
This Phase II/III randomized study will enroll 40 children with non-severe cow's milk or hen's egg allergy and randomly assign them to a rush (multiple doses in early days) or a conventional (single doses every two weeks) oral immunotherapy (OIT) protocol. Both regimens have similar dose increments and the same final protein targets (6600 mg for milk, 4680 mg for egg), with dose modifications for adverse events. The trial includes an induction phase (from one week up to seven months) to reach the target dose and a maintenance phase thereafter, with close monitoring for allergic reactions and dose adjustments as needed. Safety and tolerance will be recorded and compared between the two schedules.
Who should consider this trial
Good fit: Children aged 6–16 with confirmed mild-to-moderate cow's milk or hen's egg allergy who have sIgE 0.35–35 kUA/L and entry DBPCFC eliciting doses at or above the specified thresholds (≥22.2 mg milk protein or ≥18.5 mg egg protein) are the intended candidates.
Not a fit: Children with severe food allergy (DEFASE ≥13), uncontrolled asthma, very low or very high eliciting doses outside the entry ranges, sIgE >35 kUA/L, or other exclusionary conditions are unlikely to be eligible or to benefit from this protocol.
Why it matters
Potential benefit: If successful, the rush protocol could allow some children to reach protective tolerance more quickly, reducing treatment time while maintaining safety.
How similar studies have performed: Oral immunotherapy for milk and egg has previously achieved desensitization in many studies, but direct comparisons of rush versus conventional OIT schedules remain less common.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Madrid
- Hospital Infantil Universitario Niño Jesús. Avenida de Menéndez Pelayo, número 65 — Madrid, Spain (Recruiting)
Study contacts
- Principal investigator: Dr. Pablo Rodriguez del Río, MD, PhD — Hospital Infantil Niño Jesús, Instituto de Investigación La Princesa
- Study coordinator: Dr. Pablo Rodríguez del Río
- Email: prrio@yahoo.es
- Phone: +34915035900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.