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New study aims to unlock secrets of food allergy tolerance in kids

NCT ID NCT07419243

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at children aged 4 to 10 with mild to moderate cow's milk or egg allergies. Researchers want to find biological markers that predict whether a child will naturally outgrow their allergy or benefit from oral immunotherapy (OIT). The goal is to help families and doctors decide the best approach—waiting or treatment—by comparing tolerance rates and quality of life over two years.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 68 people

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

Started

Feb 2026

Expected to finish

Jul 2030

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

4 to 17 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: 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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, Madrid, 28009, Spain

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