Rush versus conventional oral immunotherapy for cow's milk and hen's egg allergy in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.