Evaluating Low-dose Sesame Oral Immunotherapy for Children with Sesame Allergy in a Randomized Trial

What this Trial Is About

The trial investigates low-dose oral immunotherapy OIT using sesame protein in children aged 3 to 17 years with confirmed IgE-mediated sesame allergy. It compares this treatment with standard care, which involves an elimination diet and emergency treatment. The goal is to assess whether OIT can increase tolerance to sesame and improve safety outcomes in this pediatric population. Participants are randomly assigned in a 21 ratio to either receive OIT with a daily maintenance dose of 300 mg sesame protein mixed with fruit mousse or bread, or to follow a control group that maintains a strict elimination diet without OIT. The OIT group undergoes a build-up phase lasting up to 14 months followed by 3 months of maintenance treatment. The control group is observed for one year without immunotherapy. During the study, children will be monitored for ability to tolerate sesame protein through oral food challenges, adverse events, and changes in immune responses measured by laboratory tests, skin prick tests, and basophil activation tests. The primary outcome measures tolerance to a 4000 mg dose of sesame protein up to 18 months after starting treatment. Safety and immune response data will also be collected during this period. Total participation lasts up to 18 months, with ongoing assessments throughout.

Efficacy and Safety of Low-dose Sesame Oral Immunotherapy in Pediatric Patients