A Phase 1/2 interventional study of Oral Immunotherapy and Allergenic food avoidance in Food Allergy in Children, sponsored by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa. Recruiting at 1 site in Spain. Open to participants aged 4 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa · Phase 1/2, Interventional, and Treatment
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.
376 studies on the registry are indexed under Food Hypersensitivity; 90 are open to participants now.
This study's planned enrollment of 68 is above the median of 60 across 246 interventional studies indexed under Food Hypersensitivity.
Browse Food Hypersensitivity studies →Fundación de Investigación Biomédica - Hospital Universitario de La Princesa is the lead sponsor of 35 studies on the registry; 6 are open to participants now.
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NAT-cohort:
OIT-cohort:
Exclusion Criteria:
NAT-cohort:
OIT-cohort:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cow´s milk or Hen´s egg allergic children following standard of care: allergenic food avoidance
Other: Allergenic food avoidance
Cow´s milk or Hen´s egg allergic children undergoing OIT to cow´s milk or Hen´s egg respectively
Biological: Oral Immunotherapy
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 avoidance is the standard of care for patients allergic to food
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
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
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2026 (actual). Primary completion is estimated for Dec 2029, 46 months after the start.
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Fundación de Investigación Biomédica - Hospital Universitario de La Princesa