Work Group report: Oral food challenge testing

doi:10.1016/j.jaci.2009.03.042

Journal of Allergy and Clinical Immunology

Volume 123, Issue 6, Supplement, June 2009, Pages S365-S383

https://doi.org/10.1016/j.jaci.2009.03.042 Get rights and content

Oral food challenges are procedures conducted by allergists/immunologists to make an accurate diagnosis of immediate, and occasionally delayed, adverse reactions to foods. The timing of the challenge is carefully chosen based on the individual patient history and the results of skin prick tests and food specific serum IgE values. The type of the challenge is determined by the history, the age of the patient, and the likelihood of encountering subjective reactions. The food challenge requires preparation of the patient for the procedure and preparation of the office for the organized conduct of the challenge, for a careful assessment of the symptoms and signs and the treatment of reactions. The starting dose, the escalation of the dosing, and the intervals between doses are determined based on experience and the patient's history. The interpretation of the results of the challenge and arragements for follow-up after a challenge are important. A negative oral food challenge result allows introduction of the food into the diet, whereas a positive oral food challenge result provides a sound basis for continued avoidance of the food.

Section snippets

Indications for an OFC

An OFC may be indicated to confirm that an allergic or other adverse reaction to a food or food additive exists or that it has resolved. The decision to proceed to OFC is complex and may be influenced by many factors including the patient's medical history, age, past adverse food reactions, skin prick test (SPT) and serum food-specific IgE test results, and concomitant food allergies. The decision is also influenced by the importance of the food to the patient because of its nutritional value,

Risks and benefits of an OFC

An OFC resulting in a clinical reaction is termed a positive or failed challenge, whereas an OFC without a clinical reaction is termed a negative or passed challenge. For the purpose of this document, the authors chose to use positive and negative terminology. There have been no associated deaths from OFC reported in the literature indexed since 1976 in PubMed (http://www.ncbi.nlm.nih.gov/entrez/query.fcgi). However, positive OFCs have inherent risks including acute allergic reactions with

Reasons for deferring an OFC

An OFC may be deferred if there is a high likelihood of reacting to the food as predicted by the food reaction history, whether immediate or delayed; levels of serum food-specific IgE antibody; and/or results of quantitative skin prick testing and the patient's age (Table I, Table II). OFC is relatively contraindicated in conditions that increase the risk of severe anaphylaxis, such as a recent convincing anaphylactic reaction to the food or unstable asthma. It would not be recommended to

Types of OFC

There are various types of OFC that may be clinically indicated, including open, single-blind, or double-blind, placebo-controlled. The choice of the type of OFC is based on clinical assessment of the potential for bias in the interpretation of the results (Fig 1).3, 4, 18, 25

Location of OFC

Deciding where to perform an OFC should be based on risk assessment and capacity to treat anaphylactic reactions, and practical aspects such as preparation, administration, and monitoring. Low-risk challenges in cooperative patients are appropriate for the office setting. A physician may choose to perform higher-risk OFC in the office setting based on clinical judgment and expertise, and the availability of materials and support for the treatment of a severe reaction.

The timing, type, and

Food preparation for OFC

The challenge food can be brought from home by the patient or parent for open office OFC, whereas for blind OFC, test material should be provided by a physician to ensure proper masking. The food should be prepared without cross-contamination or contact with other foods to which the patient may react and in a sanitary fashion. Preferably, single-ingredient foods should be used for OFC.

Special attention must be given to the form and degree of rawness of the food selected for an OFC. Thermal

Dosing schedule for OFC

Because the goal of an OFC is to test the patient's tolerance to a specific food in a quantity and form that will be subsequently encountered in the diet, the total quantity tested should approximate the regular, age-appropriate serving size of the food.

Obtaining consent and discussing risks and benefits

Documentation of verbal or written informed consent should be considered. Before conducting a food challenge, outcome, risks, and benefits and the implications and the potential limitations of a negative or positive challenge should be discussed with patients and/or parents. The severity of the reaction during a positive OFC should not be used to estimate the severity of future reactions. Because OFC is stopped at the first objective symptom, an exposure to a larger amount of the food may

Administering an OFC

The OFC should be conducted in a location where food may be heated and measured. A small food scale may be necessary for graduated challenges. To eliminate the risk of allergen cross-contamination, clean disposable plates, cups, utensils, and paper towels are used. The challenge area should be cleaned between challenges. For children, having familiar utensils and favorite cups and plates from home and creating a child-friendly environment can make the challenge experience more enjoyable and

Monitoring and stopping OFC

Before starting the feeding, baseline vital signs—respiratory rate, heart rate, and blood pressure—should be recorded and physical findings should be documented to serve as a reference. Recording a peak flow and spirometry may be considered, especially for patients with asthma (Fig 2). Emergency medications must be readily accessible. For high-risk challenges, it may be prudent to have epinephrine drawn up and kept in the patient's room or in an immediately accessible location and with access

Treating reactions

In case of an allergic reaction to an OFC, treatment should be initiated promptly by the person administering the challenge, according to guidelines for anaphylaxis treatment.¹²⁵ Vital signs should be obtained as soon as symptoms are noted, but obtaining them should not delay treatment when the reaction appears to require rapid intervention or to be severe. Oral antihistamines are used to treat mild reactions; parenteral antihistamines can be administered via intramuscular or intravenous

Negative OFC

The OFC is negative if the patient tolerates the entire challenge, including the masked and open portions of a blinded OFC and observation period. The patient may be discharged home after at least 1 to 2 hours of observation for the immediate-type reactions and 4 hours for food protein–induced enterocolitis syndrome. Longer observation periods may be necessary in patients with later onset of symptoms in previous reactions, such as gastrointestinal complaints and/or eczema. Depending on the

OFC for research

The following discussion is applicable to OFCs conducted for clinical research. As a result of scientific rigor, the majority of research studies use DBPCFC protocols, in which masking of challenge foods and development of placebo foods is provided by professional dietitians after extensive testing.4, 26, 29 DBPCFC can be used to determine threshold doses for the food industry—for example, for assessment of product contamination with food allergens, for monitoring the accuracy of equipment

Summary

The OFC is a valuable tool in the initial diagnosis and management of adverse food reactions including food allergy. In vivo and in vitro tests of food-specific IgE do not always correlate with clinical reactivity. OFC can be safely conducted under physician supervision, with appropriate precautions, although as noted throughout this article, the potential for serious reactions exists. Allergists/immunologists are particularly well qualified to conduct OFCs to assist patients with correct

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: Supported by the Food Allergy Initiative. The Food Allergy Initiative is a nonprofit corporation dedicated to finding a cure for food allergies by funding food allergy research; it does not conduct scientific research or render medical advice. The opinion in the manuscript reflects that of the authors and not that of the Food Allergy Initiative, and Food Allergy Initiative is not responsible or liable for the information set forth in the manuscript or for any damages that may result from its use.

: Disclosure of potential conflict of interest: A. Assa'ad has received research support from GlaxoSmithKline. A. Nowak-Węgrzyn has received research support from the National Institutes of Health. S. L. Bahna has received research support from Genentech/Novartis and CSL Behring. S. H. Sicherer has received research support from the National Institutes of Health/National Institute of Allergy and Infectious Diseases and is a consultant for the Food Allergy Initiative and a medical advisor for the Food Allergy and Anaphylaxis Network. The rest of the authors have declared that they have no conflict of interest.

^∗: Authors listed alphabetically.

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