Identification of Mechanisms and Biomarkers Predictive of Tolerance in Children With Food Allergies Comparing Oral Immunotherapy and Natural Evolution

What this Trial Is About

Researchers are investigating food allergies to cow's milk and hen's egg proteins, which are common causes of food allergies in early childhood and can lead to serious reactions, reduced quality of life, and health costs. While many children outgrow these allergies naturally by age 5, some continue to have allergies into adolescence. This study aims to compare natural allergy resolution with oral immunotherapy (OIT), a treatment that gradually introduces small amounts of the allergenic food to increase tolerance, to better understand which approach is more effective for children with mild to moderate allergies who are older than 6 years. The study includes two groups of children aged 4 to 17 years with cow's milk or hen's egg allergies. One group follows the standard care of avoiding the allergenic food, while the other undergoes OIT to build tolerance by taking increasing doses of milk or egg protein. The OIT group consists of children who have achieved full or partial desensitization after about 7 months of treatment. Both groups will be followed for up to 29 months to track their allergy status and immune responses. Participants will have regular assessments including food challenges to test tolerance, questionnaires about quality of life, and monitoring of allergic reactions. Researchers will compare how many children in each group achieve sustained unresponsiveness, meaning they can tolerate the food even after a period of avoidance. They will also evaluate quality of life changes and the safety of the treatments. The study will last about two years for the OIT group and slightly longer for the avoidance group, with ongoing follow-up to understand long-term outcomes.

Tolerance Results and Immune Mechanisms in Cow´s Milk and/or Hen´s Egg Allergic Children Following Natural Evolution or Oral Immunotherapy