Actively Recruiting
Tolerance Results and Immune Mechanisms in Cow´s Milk and/or Hen´s Egg Allergic Children Following Natural Evolution or Oral Immunotherapy
Led by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa · Updated on 2026-02-27
68
Participants Needed
1
Research Sites
231 weeks
Total Duration
On this page
Sponsors
F
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Lead Sponsor
F
Fundación para la investigación biomética Hospital Infantil Universitario Niño Jesús
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Tolerance Results and Immune Mechanisms in Cow´s Milk and/or Hen´s Egg Allergic Children Following Natural Evolution or Oral Immunotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Cow's milk and/or hen's egg allergic patients aged 4 to 10 years for the natural evolution group
- Specific IgE levels to milk or egg extracts between 0.35 to 35 kUA/L
- Positive entry open food challenge with milk/egg with oFASS5 classification 2 or higher
- Mild to moderate food allergy severity with a DEFASE score below 13 points
- Signed informed consent
- For OIT group: patients undergoing oral immunotherapy in the compITO study who have achieved full or partial desensitization by month 7
- Signed informed consent for OIT group
You will not qualify if you...
- Positive reaction in the entry open oral food challenge with a baseline eliciting dose below target ED20 for milk or egg protein
- Desire or medical indication to start OIT within 29 months of study entry (natural evolution group)
- No allergic reaction greater than oFASS5 grade 1 in baseline challenge for maximum programmed doses
- Immunological diseases or immunomodulatory/blocking therapies
- Severe atopic dermatitis by SCORAD classification
- Severe allergy with DEFASE score 13 or higher
- Moderate-to-severe airflow obstruction (FEV1 <70%)
- Poorly controlled asthma
- Previous oral immunotherapy for another food
- Recent treatment with subcutaneous or sublingual aeroallergen immunotherapy
- Presence or suspicion of eosinophilic esophagitis
- Non-IgE-mediated allergy to milk or egg
- Pregnancy
- Significant medical comorbidities such as renal, hepatic, or cardiac insufficiency, active infections, or cancers
- Inability to provide informed consent
- Communication or cognitive barriers preventing protocol adherence
- For OIT group: failure or withdrawal from the compITO study, uncontrolled atopic dermatitis or asthma, development of eosinophilic esophagitis, confirmed pregnancy, significant medical comorbidities, inability to provide informed consent, or communication/cognitive barriers
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital Infantil Universitario Niño Jesús. Avenida de Menéndez Pelayo, número 65
Madrid, Madrid, Spain, 28009
Actively Recruiting
Research Team
P
Pablo Rodríguez del Río, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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