Mechanisms of Desensitization During Peanut Oral Immunotherapy — PnOIT4  

Food Hypersensitivity Clinical Trial

Official title: Mechanisms of Desensitization During Peanut Oral Immunotherapy

Status Completed

Clinical Trial Summary

The purpose of this study is to attempt to understand how desensitization works in peanut allergic children who are undergoing oral immunotherapy (OIT) to peanut. We want to identify the early changes in the desensitization process the immune cells undergo to become desensitized to the peanut protein.

Clinical Trial Description

Peanut allergic children will undergo an oral food challenge (OFC) to 1 gm peanut protein in order to accomplish two objectives: (1)to confirm the diagnosis of peanut allergy, and (2) to measure the amount of peanut protein it takes to cause an allergic reaction. Each subject will then undergo a modified rush phase in which the subject receives 6 doses of peanut protein in one day. The build-up phase begins afterward in which the subject's dose of peanut protein is increased every 2 weeks for 36 weeks. After the final build-up dose, the subject consumes that dose for 2 weeks after which he or she returns to the food allergy center for the second food challenge. If the subject successfully consumes this food challenge without symptoms, the daily dosing of peanut protein will be stopped and the subject will then undergo a third food challenge. If the subject successfully consumes the peanut protein during that challenge, he or she will return for a fourth food challenge to peanut. ;

Related Conditions & MeSH terms

• Food Hypersensitivity
• Hypersensitivity

• NCT number: NCT01814241
• Study type: Interventional
• Source: University of North Carolina, Chapel Hill
• Status: Completed
• Phase: Phase 2
• Start date: April 2013
• Completion date: December 2015