Comparing Rush Versus Conventional Oral Immunotherapy for Treating Milk and Egg Allergies in Children Ages 6 to 16

What this Trial Is About

Researchers are evaluating two different oral immunotherapy OIT approaches to treat children aged 6 to 16 with milk and egg allergies. This Phase IIIII randomized clinical trial compares a rapid rush OIT protocol with a conventional OIT protocol, aiming to assess their safety and effectiveness. Milk and egg allergies are common food allergies, and improving treatment methods could help more children undergo safer and more efficient therapy. The study involves two OIT schemes the rush regimen administers several incremental doses daily over the first week, while the conventional regimen gives single incremental doses every two weeks during the induction phase lasting from 1 week up to 7 months. Participants with milk or egg allergies receive incremental doses until reaching a target protein amount 6600 mg for milk, 4680 mg for egg. After induction, they continue a maintenance phase where milk is taken daily and egg every 48 hours, continuing until the study ends at 7 months. Participants will be monitored closely throughout the induction and maintenance phases. Assessments include recording adverse events, measuring tolerance levels through food challenges, evaluating quality of life with questionnaires, and analyzing immunological changes and biomarkers. Safety is a primary focus, with adjustments made for adverse reactions. The study will capture detailed data on treatment burden and molecular changes, with total participation lasting 7 months.

Comparison Between a Rush and a Conventional Oral Immunotherapy Protocol to Treat Cow's Milk and Hen´s Egg Allergy. CompITO Study