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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-03

Study Completion Date

2027-04-30

Brief Summary

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

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Detailed Description

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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

Conditions

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Food Allergy in Children Milk Allergy Egg Allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rush protocol

Milk and egg allergic children undergoing OIT following a Rush regimen

Group Type EXPERIMENTAL

"Rush" regimen

Intervention Type BIOLOGICAL

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 protocol

Milk and egg allergic children undergoing OIT following a Conventional regimen

Group Type ACTIVE_COMPARATOR

"Conventional" regimen

Intervention Type BIOLOGICAL

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

Interventions

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"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)

Intervention Type BIOLOGICAL

"Conventional" regimen

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)

Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No