Comparing the Safety and Effectiveness of 4-Step Versus 6-Step Milk Ladders in Children Aged 1 to 5 With IgE-Mediated Cows Milk Protein Allergy

What this Trial Is About

Cows milk protein allergy CMPA is a common food allergy in young children, and the main treatment is avoiding cows milk proteins. Researchers are studying how children with IgE-mediated CMPA develop tolerance to cows milk proteins over time. This trial compares the effectiveness and safety of two milk introduction methods called the 4-step milk ladder 4-ML and the 6-step milk ladder 6-ML to see which better helps children build tolerance to cows milk. Children aged 1 to 5 years with IgE-mediated CMPA will be randomly assigned to follow either the 4-step or 6-step milk ladder protocol. Both involve gradually introducing baked and non-heated milk products in increasing amounts with a 4-week break between each step. Oral food challenges OFCs will be done in the hospital at each step to test tolerance. The 4-ML group will be observed for 12 weeks, while the 6-ML group for 20 weeks. During the study, children will be monitored for allergic reactions, including anaphylaxis and atopic dermatitis flare-ups, growth changes, and treatment adherence. Parents anxiety and quality of life will also be assessed. The main measurement is the percentage of children who tolerate non-heated cows milk proteins without reaction at the end of the observation period. The study will evaluate these outcomes through clinical tests and questionnaires over the treatment duration.

Effectiveness and Safety of Milk Ladders in Children with IgE-Mediated Cow's Milk Protein Allergy