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.
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)
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.
Parallel
Oral Immunotherapy
Biological/VaccineOIT 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
Other interventionAllergenic 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
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)
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
Comparison of the median burden of treatment score in the OIT-cohort at the end of study (24 months)
Click on the lead sponsor to view all of their trials.
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Lead sponsor
Fundación para la investigación biomética Hospital Infantil Universitario Niño Jesús
Collaborator
