Food Allergy in ChildrenPhase 1/2alerITONCT07419243
Tolerance Results and Immune Mechanisms in Cow´s Milk and/or Hen´s Egg Allergic Children Following Natural Evolution or Oral Immunotherapy
A Phase 1/2 study testing Oral Immunotherapy and Allergenic food avoidance in people with Food Allergy in Children, run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa at 1 site in Spain.
Trial summary
Allergy to Cow's milk and hen´s egg proteins are the most common causes of food allergies in early childhood and are associated with the occurrence of adverse events that may be life-threatening, quality of life impairment and negative nutritional and health economic impact. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Food Allergy in Children
- What is being tested?
- Oral Immunotherapy and Allergenic food avoidance
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSpain
- Study dates
- 18 Feb 2026to 30 Jul 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 25Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Infantil Universitario Niño Jesús. Avenida de Menéndez Pelayo, número 65
Madrid, Madrid, 28009
Pablo Rodríguez del Río, MD PhD, +34915035900, prodriguezd@salud.madrid.org
About this study
Official title: Identification of Mechanisms and Biomarkers Predictive of Tolerance in Children With Food Allergies: Comparison Between Treatment With Oral Immunotherapy and Natural Evolution. alerITO Study
Allergy to Cow's milk and hen´s egg proteins are the most common causes of food allergies in early childhood and are associated with the occurrence of adverse events that may be life-threatening, quality of life impairment and negative nutritional and health economic impact.
However, contrarily to other food allergy models such as nuts/peanut allergy, milk and egg allergy have greater chances of natural resolution. While around 50% of children may outgrow milk or egg allergy by the age of 5 years old, only 22% of peanut allergic children at the age of 4 years can tolerate this food. However, it is also documented that, at 14 years of age, the persistence of milk and egg allergy still affects around 30% of these children.
Read more
Standard of care relies on food avoidance and treatment of accidental reactions, but this approach is unsatisfactory because adverse events and quality of life limitations still remain. Milk and egg Oral Immunotherapy (OIT) is the most promising therapeutic alternative and showed good results to induce Desensitization (ability to tolerate the food while it is regularly taken) but insufficient efficacy to achieve Sustained Unresponsiveness (SU) (ability to tolerate the food after a period of avoidance).
In the day-to-day practice, families and allergists of milk and egg allergic children frequently face the following dilemma: what is the best approach? Keep waiting for natural resolution or embarking in OIT? At the moment, there are only very limited data to guide this decision, specially in children with mild to moderate allergy, that still after 6 years of age withhold relevant chances of naturally outgrowing their allergy.
Our objective is conducting a longitudinal cohort-study of children undergoing food avoidance and children undergoing OIT to assess biomarkers of natural allergy resolution/persistence and OIT Desensitization/Sustained Unresponsiveness trajectories.
- Conditions
- Food Allergy in Children
- Being tested
- Oral Immunotherapy, Allergenic food avoidance
- Keywords
- Oral immunotherapy, Food allergy, Children, Hen´s egg allergy, Cow´s milk allergy, Desensitization, Sustained Unresponsiveness, Biomarkers, Natural evolution, Microbiota, OIT, Quality of Life, FAQLQ, Burden of treatment
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral ImmunotherapyBiological
OIT is a treatment where incremental doses of a food causing allergy to a patient are given until a target maintenance dose is reached, to increase his/her reactivity threshold
Allergenic food avoidanceOther
Allergenic food avoidance is the standard of care for patients allergic to food
| Study group | Role | What they receive |
|---|---|---|
| NAT-cohort | Other | Cow´s milk or Hen´s egg allergic children following standard of care: allergenic food avoidance Receives: Other: Allergenic food avoidance |
| OIT-cohort | Active comparator | Cow´s milk or Hen´s egg allergic children undergoing OIT to cow´s milk or Hen´s egg respectively Receives: Biological: Oral Immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the proportion of patients achieving SU in the OIT-cohort after 2 years of OIT treatment vs the proportion of patients achieving natural resolution after 2 years of follow up
Measured: Month 19 of the study in the OIT-cohort and Month 24 in the NAT-cohort
Secondary outcomes (3)
Comparison of the median Food Allergy Quality of Life Questionnaire, Parental Form (FAQLQ-PF) score change in patients in the OIT-cohort vs NAT-cohort between baseline and end of study (month 24 for OIT cohort, month 29 for the NAT cohort)
Measured: End of study in OIT-cohort: Month 24; End of study in NAT-cohort: Month 29
Number of adverse events with an ordinal Food Allergy Severity Score 5 (oFASS5) ≥2 reported until the end of study in both cohorts, NAT vs ITO
Measured: End of study in OIT-cohort: Month 24; End of study in NAT-cohort: Month 29
Comparison of the median burden of treatment score in the OIT-cohort at the end of study (24 months)
Measured: End of study in OIT-cohort: Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start18 Feb 2026
- Primary completion30 Dec 2029 (estimated)
- Study completion30 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food Allergy in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación para la investigación biomética Hospital Infantil Universitario Niño Jesús
- Responsible party
- Principal investigator, Pablo Rodríguez del Rio, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419243
- Sponsor's protocol ID
- R-0011/26
- Acronym
- alerITO
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Mechanisms and Biomarkers Predictive of Tolerance in Children With Food Allergies: Comparison Between Treatment With Oral Immunotherapy and Natural Evolution. alerITO Study
- ClinicalTrials.gov ID
- NCT07419243
- Acronym / sponsor ID
- alerITO / R-0011/26
- Conditions
- Food Allergy in Children
- Keywords
- Oral immunotherapy, Food allergy, Children, Hen´s egg allergy, Cow´s milk allergy, Desensitization, Sustained Unresponsiveness, Biomarkers
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La PrincesaUniversity, hospital or other
- Collaborators
- Fundación para la investigación biomética Hospital Infantil Universitario Niño Jesús
- Study start
- 18 Feb 2026 (actual)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 Jul 2030 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Allergy to Cow's milk and hen´s egg proteins are the most common causes of food allergies in early childhood and are associated with the occurrence of adverse events that may be life-threatening, quality of life impairment and negative nutritional and health economic impact.
However, contrarily to other food allergy models such as nuts/peanut allergy, milk and egg allergy have greater chances of natural resolution. While around 50% of children may outgrow milk or egg allergy by the age of 5 years old, only 22% of peanut allergic children at the age of 4 years can tolerate this food. However, it is also documented that, at 14 years of age, the persistence of milk and egg allergy still affects around 30% of these children.
Standard of care relies on food avoidance and treatment of accidental reactions, but this approach is unsatisfactory because adverse events and quality of life limitations still remain. Milk and egg Oral Immunotherapy (OIT) is the most promising therapeutic alternative and showed good results to induce Desensitization (ability to tolerate the food while it is regularly taken) but insufficient efficacy to achieve Sustained Unresponsiveness (SU) (ability to tolerate the food after a period of avoidance).
In the day-to-day practice, families and allergists of milk and egg allergic children frequently face the following dilemma: what is the best approach? Keep waiting for natural resolution or embarking in OIT? At the moment, there are only very limited data to guide this decision, specially in children with mild to moderate allergy, that still after 6 years of age withhold relevant chances of naturally outgrowing their allergy.
Our objective is conducting a longitudinal cohort-study of children undergoing food avoidance and children undergoing OIT to assess biomarkers of natural allergy resolution/persistence and OIT Desensitization/Sustained Unresponsiveness trajectories.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAT-cohort | Other | Other: Allergenic food avoidanceCow´s milk or Hen´s egg allergic children following standard of care: allergenic food avoidance |
| OIT-cohort | Active comparator | Biological: Oral ImmunotherapyCow´s milk or Hen´s egg allergic children undergoing OIT to cow´s milk or Hen´s egg respectively |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral ImmunotherapyOIT is a treatment where incremental doses of a food causing allergy to a patient are given until a target maintenance dose is reached, to increase his/her reactivity threshold | Biological | OIT-cohort |
| Allergenic food avoidanceAllergenic food avoidance is the standard of care for patients allergic to food | Other | NAT-cohort |
Primary outcome
Comparison of the proportion of patients achieving SU in the OIT-cohort after 2 years of OIT treatment vs the proportion of patients achieving natural resolution after 2 years of follow up
Time frame: Month 19 of the study in the OIT-cohort and Month 24 in the NAT-cohort
3 secondary outcomes
Comparison of the median Food Allergy Quality of Life Questionnaire, Parental Form (FAQLQ-PF) score change in patients in the OIT-cohort vs NAT-cohort between baseline and end of study (month 24 for OIT cohort, month 29 for the NAT cohort)
Time frame: End of study in OIT-cohort: Month 24; End of study in NAT-cohort: Month 29
Number of adverse events with an ordinal Food Allergy Severity Score 5 (oFASS5) ≥2 reported until the end of study in both cohorts, NAT vs ITO
Time frame: End of study in OIT-cohort: Month 24; End of study in NAT-cohort: Month 29
Comparison of the median burden of treatment score in the OIT-cohort at the end of study (24 months)
Time frame: End of study in OIT-cohort: Month 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Oral Immunotherapy and Allergenic food avoidance in people with Food Allergy in Children, run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pablo Rodríguez del Río, MD PhD (+34915035900, prrio@yahoo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the proportion of patients achieving SU in the OIT-cohort after 2 years of OIT treatment vs the proportion of patients achieving natural resolution after 2 years of follow up (time frame: Month 19 of the study in the OIT-cohort and Month 24 in the NAT-cohort). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.