New study aims to unlock secrets of food allergy tolerance in kids
NCT ID NCT07419243
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 68 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Jul 2030
An estimate. End dates often move.
- Lead sponsor
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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
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4 to 17 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Hospital Infantil Universitario Niño Jesús. Avenida de Menéndez Pelayo, número 65
RECRUITINGMadrid, Madrid, 28009, Spain
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