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Baked milk oral immunotherapy can effectively desensitize children suffering from cow’s milk allergy while reducing the likelihood of severe adverse reactions.
In a new phase II randomized clinical trial, baked milk oral immunotherapy (BMOIT) helped children with cow’s milk allergy build tolerance while maintaining a favorable safety profile.
In young children, cow’s milk allergy is the most prevalent food allergy. While oral immunotherapy (OIT) has been shown to be useful, it often elicits a high rate of allergic reactions, limiting its widespread use. Hence, researchers explored whether baked milk—a less allergenic form due to heat-induced protein modifications—could offer a safer approach to desensitization. The study involved children (aged 3–18 years) with confirmed cow’s milk allergy.
Initially, some participants received BMOIT while others received a placebo. After 1 year, those in the placebo arm crossed over to active intervention. To measure desensitization, the researchers executed double-blind, placebo-controlled oral food challenges. After 1 year, participants were challenged with baked milk. After 2 years, those who completed treatment were challenged with both baked and unheated milk. The study also analyzed immune system changes by quantifying IgE and IgG antibody levels and profiling cow’s milk-specific CD4+ memory T cells via advanced flow cytometry and single-cell RNA sequencing.
The results depicted noteworthy desensitization among volunteers:
Immunological changes were strongly linked to successful desensitization. Those who tolerated more milk showed:
These findings not only confirm the safety and efficacy of BMOIT but also offer novel insights into the immune shifts behind food allergy tolerance. If widely adopted, BMOIT could transform milk allergy care in children, offering a practical and less risky path to long-term tolerance.
JCI Insight
Clinical and immunological outcomes after randomized trial of baked milk oral immunotherapy for milk allergy
Jennifer A Dantzer et al.
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