Oral immunotherapy versus natural course for milk and egg allergy in children

Identification of Mechanisms and Biomarkers Predictive of Tolerance in Children With Food Allergies: Comparison Between Treatment With Oral Immunotherapy and Natural Evolution. alerITO Study

This study will see if oral immunotherapy helps children aged 4–10 with cow's milk or hen's egg allergy become desensitized compared with natural evolution.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Ages: 4 Years to 17 Years
• Sex: All
• Sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa (Academic / other)
• Drugs / interventions: Immunotherapy
• Locations: 1 site (Madrid, Madrid)
• Trial ID: NCT07419243 on ClinicalTrials.gov

What this trial studies

This interventional Phase 1/2 study compares children managed with natural evolution to children who undergo oral immunotherapy (OIT) to characterize tolerance outcomes and underlying immune mechanisms. Eligible children are 4–10 years old with confirmed milk and/or egg allergy by positive open food challenge and specified sIgE ranges, while the OIT cohort includes participants from the companion compITO study who achieved partial or full desensitization by month 7. Outcomes include tolerance measured by food challenge (oFASS5 classification) and immunologic biomarkers to map mechanisms of desensitization or persistence. The trial is conducted at Hospital Infantil Universitario Niño Jesús in Madrid with standardized challenge and monitoring procedures.

Who should consider this trial

Good fit: Ideal candidates are children aged 4–10 with confirmed cow's milk and/or hen's egg allergy (sIgE 0.35–35 kUA/L) who have a positive entry open food challenge and mild-to-moderate severity, or children from the compITO study who achieved partial or full desensitization by month 7.

Not a fit: Children with severe food allergy beyond the trial's inclusion criteria, those outside the specified age or sIgE ranges, or those unable to tolerate challenge procedures are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the approach could increase the number of children who tolerate milk or egg and reduce allergic reactions and daily burdens for families.

How similar studies have performed: Previous OIT studies for milk and egg have produced desensitization in many children, though long-term sustained tolerance rates vary and some patients still have persistent allergy.

Eligibility criteria

Inclusion Criteria:

NAT-cohort:

* Cow´s Milk and/or Hen´s Egg allergic patients 4 to 10 years old
* sIgE levels to milk OR egg extracts between 0.35 to 35kUA/L
* Positive entry Open food challenge with milk/egg with oFASS5 classification ≥2 with a maximum cumulative dose of up to 4193.7 mg of milk protein or 3110.8 mg of egg white protein
* Having a mild to moderate food allergy severity per the Definition of Food Allergy Severity (DEFASE) score (\<13 points)
* Having signed the informed consent

OIT-cohort:

* Patients in the compITO study (NCT06976775) who are undergoing OIT and have achieved full desensitization to the food by month 7 of the study (end of study)
* Patients in the compITO study who are undergoing OIT and have achieved partial desensitization (tolerating a dose lower than the total dose, and a minimum of 3 doses above the entry challenge threshold) to the food by month 7 of the study (end of study)
* Having signed the informed consent

Exclusion Criteria:

NAT-cohort:

* Positive reaction in the entry open oral food challenge with a baseline Eliciting Dose (ED) 20 below the target ED20 for food. For milk, 23.1 mg (35.7 mg cumulative) of protein, or for egg, 19.5 mg (29.4 mg cumulative) of protein.
* Patient desire or medical indication to initiate OIT at any time within 29 months of study entry.
* No allergic reaction greater than oFASS5 grade 1 in the baseline challenge for the maximum cumulative programmed doses of 4193.7 mg of milk protein, or 3110.8 mg of egg white protein.
* Immunological diseases, immunomodulatory/blocking therapies.
* Severe atopic dermatitis according to the SCORing Atopic Dermatitis (SCORAD) classification
* Severe allergy, according to a DEFASE score ≥13
* Spirometry values with moderate-to-severe airflow obstruction (FEV1 \<70%)
* Poorly controlled asthma according to clinical criteria
* Previous OIT for another food
* Within the first 3 months of treatment with Subcutaneous Aeroallergen Immunotherapy
* Within the first week of treatment with Sublingual Aeroallergen Immunotherapy
* Presence or suspicion of Eosinophilic Esophagitis
* Non-IgE-mediated allergy to milk or egg
* Pregnancy
* Significant medical comorbidities (renal, hepatic, or cardiac insufficiency, active infectious diseases, previous or concurrent cancers)
* Inability to provide informed consent
* Communication or cognitive barriers that prevent adherence to the protocol

OIT-cohort:

* Patients enrolled in the compITO study who have failed or withdrawn from the study for any reason.
* Patients with uncontrolled Atopic Dermatitis or Asthma at the time of enrolment, or who have developed Eosinophilic Esophagitis.
* Patients with confirmed pregnancy at the time of enrolment.
* Patients who have developed significant medical comorbidities (renal, hepatic, or cardiac insufficiency, active infectious diseases, previous or concurrent cancers) at the time of enrolment.
* Inability to provide informed consent.
* Communication or cognitive barriers that prevent adherence to the protocol.

Where this trial is running

Madrid, Madrid

• Hospital Infantil Universitario Niño Jesús. Avenida de Menéndez Pelayo, número 65 — Madrid, Madrid, Spain (Recruiting)

Study contacts

• Study coordinator: Pablo Rodríguez del Río, MD PhD

Conditions Food Allergy in Children; Oral immunotherapy; Food allergy; Children; Hen´s egg allergy; Cow´s milk allergy; Desensitization; Sustained Unresponsiveness