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Fast vs. slow: which oral allergy treatment works best for kids?

NCT ID NCT06976775

Disease control Sponsor: Pablo Rodríguez del Rio Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two ways of giving oral immunotherapy to children aged 6–16 with milk or egg allergy. One method uses daily increasing doses over a week ('rush'), while the other uses doses every two weeks ('conventional'). The goal is to see which is safer and more effective at helping children tolerate these foods, and to find biological markers that predict success.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
oral immunotherapy (milk or egg protein)
What this could lead to
If successful, this could identify a safer, more efficient way to desensitize children to milk or egg, reducing allergic reactions from accidental exposure.
What could go wrong
This is a small, early-phase trial (Phase 2/3) with only 40 children. The faster 'rush' regimen may cause more side effects, and results may not apply to all allergic children.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 16 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

allergic disease anaphylaxis Egg Hypersensitivity food allergy Heiner syndrome Milk Hypersensitivity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Egg allergy Food allergy in children Milk allergy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital Infantil Universitario Niño Jesús. Avenida de Menéndez Pelayo, número 65

    RECRUITING

    Madrid, 28009, Spain

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