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

Pablo Rodríguez del Rio

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Milk Allergy; Food Allergy in Children; Egg Allergy

Treatments: Biological: "Conventional" regimen; Biological: "Rush" regimen

Study type: Interventional

Funder types: Other

Identifiers

NCT06976775

compITO

Details and patient eligibility

About

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

Full description

Food immunotherapy, especially oral immunotherapy (OIT), is now a standard treatment option for patients allergic to cow´s milk, hen´s egg or peanuts. While peanut OIT has drawn considerable attention from the scientific community, milk and hen´s egg OIT still remain as the most common immunotherapy administered in daily routine. Optimization of these treatments is a priority to offer to a wider number of candidates a more efficient and safe way of treatment.

A Phase II/III randomized clinical trial enrolling a total of 40 patients with non-severe food allergies (20 cow's milk allergic children and 20 hen's egg allergic children) to assess the safety and efficacy of a rush/rapid versus a conventional OIT protocol.

Schemes are comparable in terms of the number of doses, the relative increment between doses and the final amount of protein, with one exception: the "rush" regimen includes several doses given the same day over the first week of treatment while in the "conventional" regimen Induction Phase is based upon single doses given every 2 weeks.

There are two different parts in the study, during Induction Phase (Part 1, 1 week up to 7 months), participants in both groups will receive incremental doses of milk/egg, depending on their allergy, until they tolerate 6600 mg or 4680mg of milk or egg protein respectively. The occurrence of adverse events in both groups will result in dose adjustments and delay in completion Induction Phase. During Maintenance Phase (Part 2), patients will ingest the same dose (daily for milk and every 48h for egg) until the end of study, that will last for a total duration of 7 months.

The study features a dual primary outcome. Safety and efficacy variables are primary outcomes, and parents and patient-reported food allergy-related quality of life (HRQoL) are secondary outcomes, as well as burden of treatment and immunological changes. Molecular changes underlying OIT will be studied, and biomarkers of safety and efficacy will be sought

Enrollment: 40 estimated patients

Sex: All

Ages: 6 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Rush protocol

Experimental group

Description:

Milk and egg allergic children undergoing OIT following a Rush regimen

Treatment:

Biological: "Rush" regimen

Conventional protocol

Active Comparator group

Description:

Milk and egg allergic children undergoing OIT following a Conventional regimen

Treatment:

Biological: "Conventional" regimen