A model test system for food allergy ingestion challenge study

Abstract

The aim of this paper is to propose a standardized mathematical model to be used as a reference for future studies. The mathematical model is presented for oral food ingestion challenge single-blind study, controlled with placebo. This model will meet the increasing demand for an easily used, valid and reproducible clinical rating scale that is sufficiently sensitive and discriminatory to accurately assess the effects of various treatment regimens on the food-allergic patient. The model assumes that at least a fraction of ingested food antigen circulates in the patient's blood stream, the resultant antigenemia thereby provides a stimulus-response signal in the susceptible host. The testing regimen will include subjective symptoms measurements and objective, diagnostic measurements. Accumulated data will be transformed to a unified factorial rating score system which will allow examination of relevant profiles and correlations within the subject and the patient groups. Care has been taken to keep the mathematics to a minimum to assure that any properly motivated investigator with cooperative patients can implement the model, with the aid of a hand calculator.