Study of Oral Immunotherapy Using Cashew Nut Protein for Children With Cashew Allergy Ages 4 to 17

What this Trial Is About

Researchers are evaluating oral immunotherapy with cashew protein compared to standard treatment through an elimination diet in children aged 4 to 17 years with IgE-mediated cashew allergy. This randomized controlled trial aims to find a safe and effective alternative to avoiding cashew, which can cause severe allergic reactions. The study includes 39 children confirmed allergic by an initial oral food challenge. Participants are randomly assigned in a 21 ratio to receive either oral immunotherapy or standard care. The immunotherapy group undergoes a build-up phase lasting up to 60 weeks, where doses of cashew protein flour are gradually increased every two weeks in a hospital setting. After reaching a maintenance dose of 1200 mg daily, they continue this dose for approximately 12 weeks. The control group avoids cashew during the study but may be offered immunotherapy afterward if it proves effective. During the study, children will have regular assessments including oral food challenges to determine tolerance to cashew protein, skin prick tests, and measurements of immune responses such as specific IgE and IgG4 levels. Safety is monitored by tracking adverse events. Quality of life related to food allergy is also evaluated. The main outcome is the ability to tolerate a full dose of 4043 mg cashew protein after treatment, with total participation lasting over a year including build-up and maintenance phases.

Efficacy of Cashew Nut Protein Immunotherapy