scholarly journals Oral food challenges

2020 ◽  
Vol 2 (1) ◽  
pp. 31-34
Author(s):  
Amal H. Assa’ad
Keyword(s):  
Food Allergy ◽  
Peanut Allergy ◽  
Food Challenge ◽  
Oral Food Challenge ◽  
Allergic Reactions ◽  
Double Blind ◽  
Trained Personnel ◽  
Open Food Challenge ◽  
Food Challenges ◽  
Shed Light

Oral food challenge (OFC) is a procedure that is conducted most commonly by allergist/immunologists in their office or in food allergy centers to confirm a food allergy or to confirm tolerance to the food. The procedure as conducted in clinical practice is mostly open food challenge and, in research, a double-blind, placebo controlled food challenge. OFC has associated risks that can be minimized by having the challenges conducted by trained personnel who are prepared to treat allergic reactions and who have rescue medications available. However, OFCs have tremendous benefits to the patients and their families, including the potential to determine that a food is no longer an allergen and can be introduced into the diet. Even OFCs that result in clinical reactions have the benefit of confirming the food allergy and demonstrating the therapeutic effect of the rescue medications. The study of the outcomes of OFC has shed light on food allergy reactions and characteristics of the patients with food allergy as well as on the value of other diagnostic tests compared with OFC. OFCs have helped establish food allergy thresholds, confirm that subjects enrolled in research studies have the allergy, and demonstrate the response to the therapies tested in terms of ameliorating the allergic response or raising the reaction threshold. OFCs have also been used to promote the recent guidelines for the prevention of peanut allergy by identifying the infants at risk for peanut allergy but who are not allergic yet.

scholarly journals Oral immunotherapy for treatment of peanut allergy

2020 ◽  
Vol 68 (6) ◽  
pp. 1152-1155
Author(s):  
Joan H Dunlop
Keyword(s):  
Food Allergy ◽  
Peanut Allergy ◽  
Food Challenge ◽  
Oral Immunotherapy ◽  
Peanut Protein ◽  
Subcutaneous Immunotherapy ◽  
Double Blind ◽  
The Us ◽  
Allergy Prevalence

The US Food and Drug Administration’s approval of a peanut oral immunotherapy product in January 2020 is a landmark development in the field of food allergy therapy. While food allergy prevalence has been increasing, this product is the first approved therapy for food allergy. Oral immunotherapy has many similarities to subcutaneous immunotherapy and drug desensitization protocols, but does not lead to sustained unresponsiveness. The studies leading to approval of the Palforzia product demonstrated increase in the amount of peanut protein able to be consumed, with 67% of subjects randomized to the treatment arm able to consume 600 mg of peanut protein in double-blind placebo-controlled food challenge at study exit. However, side effects are an important consideration, and dropout rates in studies of Palforzia ranged from 11% to 21%. Postmarketing surveillance of this product will be critical in assessing its long-term risks and benefits.

A phase II, randomized, double‑blind, parallel‑group, placebo‑controlled oral food challenge trial of Xolair (omalizumab) in peanut allergy

2011 ◽  
Vol 127 (5) ◽  
pp. 1309-1310.e1 ◽  
Author(s):  
Hugh A. Sampson ◽  
Donald Y.M. Leung ◽  
A. Wesley Burks ◽  
Gideon Lack ◽  
Sami L. Bahna ◽  
...  
Keyword(s):  
Phase Ii ◽  
Peanut Allergy ◽  
Food Challenge ◽  
Oral Food Challenge ◽  
Double Blind ◽  
Parallel Group

scholarly journals Detection of Salivary Tryptase Levels in Children following Oral Food Challenges

2021 ◽  
pp. 1-4
Author(s):  
Wouter W. de Weger ◽  
Vibeke M. Bruinenberg ◽  
Evelien M. van der Lek ◽  
Jeroen H. Gerrits ◽  
Lidy van Lente ◽  
...  
Keyword(s):  
Food Allergy ◽  
Limit Of Detection ◽  
Food Challenge ◽  
Oral Food Challenge ◽  
Potential Association ◽  
The Mean ◽  
Food Challenges ◽  
Assay Precision ◽  
Objective Marker ◽  
Time Point

<b><i>Background:</i></b> Oral food challenge (OFC) is commonly used to diagnose food allergy. This test is time and resource intensive, and conclusions are not always unequivocal as this relies on the interpretation of symptoms. Therefore, an objective marker would improve the accuracy of the diagnostic workup of food allergy. <b><i>Objectives:</i></b> The aim of this study was to investigate whether tryptase can be detected in saliva of children following OFC. <b><i>Method:</i></b> Children from 3 to 18 years of age were eligible for inclusion if an OFC for peanut or tree nut had been recommended. Saliva samples were collected prior to the first dose and 5, 10, and 15 min following the last administered dose during OFC. Assay precision, spike-and-recovery, and assessment of lower limit of detection of the tryptase immunoassay were examined before analysis of tryptase in saliva was performed. <b><i>Results:</i></b> A total of 30 children were included (median age 8 years, 63.3% male, 53.3% positive OFC outcome). Tryptase was detected in saliva samples. The mean of the change in baseline tryptase value to each saliva collecting time point was significantly different in patients with a positive OFC outcome compared to a negative outcome (<i>p</i> &#x3c; 0.01). <b><i>Conclusions:</i></b> This study showed that tryptase can be detected in saliva of children following OFC. Increased levels of tryptase compared to baseline were found if the OFC outcome was positive, suggesting that measuring tryptase in saliva may be useful in the diagnosis of food allergy. Further research is needed to evaluate the potential association between tryptase levels and symptoms.

MILESTONES MARKING THE KNOWLEDGE OF ADVERSE REACTIONS TO FOOD IN THE DECADE OF THE 1980s

PEDIATRICS ◽  
1995 ◽  
Vol 96 (2) ◽  
pp. 380-381
Author(s):  
Betty Miller
Keyword(s):  
Food Allergy ◽  
Adverse Reactions ◽  
Food Additives ◽  
Food Challenge ◽  
Cross Reactivity ◽  
Allergic Reactions ◽  
Double Blind ◽  
Specific Patient ◽  
Clinical Sensitivity ◽  
A Prospective Study

Purpose of the Study. This study outlines the significant advances made to our understanding of adverse reactions to foods and food additives in the last decade. The milestones are listed in order of overall importance and are discussed in depth in the review. 1. Establishing double-blind, placebo-controlled food challenge (DBPCFC) as the "gold-standard" for defining specific patient population to be used in scientific studies. (VanMetre, May, Bock) 2. Recognition of the key role food allergy plays in the pathogenesis of atopic dermatitis. (Sampson, May) 3. Identifying the group of foods most likely to be associated with true allergic reactions. Analysis of DBPCFC in children has shown that 93% of allergic reactions occurred to eight foods (in order of frequency): egg, peanut, milk, soy, tree nuts, crustacean-type shellfish, fish, and wheat. Corn and chocolate allergy was rarely found. (Bock, Sampson, Atkins) 4. Food allergy has a natural history. In a prospective study of 501 children, Bock found that, of 15 cases of allergy proven by DBPCFC in the first year of life, none of the 15 cases was reactive beyond 24 months of age. In contrast, long-term follow-up of patients who have experienced peanut anaphylaxis revealed that clinical sensitivity lasts for at least 14 years. (Bock, Atkins) 5. Food allergy cross-sensitivity (clinical reactivity) does not extend equally to all members of a biologic food family. Although immunologic cross-reactivity between peanut, soy, and other peas/beans could be regularly found in allergic patients, clinically important cross-reactions demonstrated by DBPCFC were rare. (Bernhisel -Broadbent, Sampson)

scholarly journals Analysis of a Large Standardized Food Challenge Data Set to Determine Predictors of Positive Outcome Across Multiple Allergens

2018 ◽  
Vol 9 ◽  
Author(s):  
Sayantani Sindher ◽  
Andrew J. Long ◽  
Natasha Purington ◽  
Madeleine Chollet ◽  
Sara Slatkin ◽  
...  
Keyword(s):  
Food Allergy ◽  
Food Challenge ◽  
Diagnostic Methods ◽  
Population Characteristics ◽  
Food Allergies ◽  
Double Blind ◽  
Data Set ◽  
Prick Test ◽  
Increased Risk ◽  
Food Challenges

Background: Double-blind placebo-controlled food challenges (DBPCFCs) remain the gold standard for the diagnosis of food allergy; however, challenges require significant time and resources and place the patient at an increased risk for severe allergic adverse events. There have been continued efforts to identify alternative diagnostic methods to replace or minimize the need for oral food challenges (OFCs) in the diagnosis of food allergy.Methods: Data was extracted for all IRB-approved, Stanford-initiated clinical protocols involving standardized screening OFCs to a cumulative dose of 500 mg protein to any of 11 food allergens in participants with elevated skin prick test (SPT) and/or specific IgE (sIgE) values to the challenged food across 7 sites. Baseline population characteristics, biomarkers, and challenge outcomes were analyzed to develop diagnostic criteria predictive of positive OFCs across multiple allergens in our multi-allergic cohorts.Results: A total of 1247 OFCs completed by 427 participants were analyzed in this cohort. Eighty-five percent of all OFCs had positive challenges. A history of atopic dermatitis and multiple food allergies were significantly associated with a higher risk of positive OFCs. The majority of food-specific SPT, sIgE, and sIgE/total IgE (tIgE) thresholds calculated from cumulative tolerated dose (CTD)-dependent receiver operator curves (ROC) had high discrimination of OFC outcome (area under the curves &gt; 0.75). Participants with values above the thresholds were more likely to have positive challenges.Conclusions: This is the first study, to our knowledge, to not only adjust for tolerated allergen dose in predicting OFC outcome, but to also use this method to establish biomarker thresholds. The presented findings suggest that readily obtainable biomarker values and patient demographics may be of use in the prediction of OFC outcome and food allergy. In the subset of patients with SPT or sIgE values above the thresholds, values appear highly predictive of a positive OFC and true food allergy. While these values are relatively high, they may serve as an appropriate substitute for food challenges in clinical and research settings.

scholarly journals Confirmed Hypoallergenicity of a Novel Whey-Based Extensively Hydrolyzed Infant Formula Containing Two Human Milk Oligosaccharides

Nutrients ◽  
2019 ◽  
Vol 11 (7) ◽  
pp. 1447 ◽  
Author(s):  
Nowak-Wegrzyn ◽  
Czerkies ◽  
Reyes ◽  
Collins ◽  
Heine
Keyword(s):  
Lower Bound ◽  
Human Milk ◽  
Food Challenge ◽  
Human Milk Oligosaccharides ◽  
Milk Oligosaccharides ◽  
Double Blind ◽  
Intention To Treat ◽  
Open Food Challenge ◽  
Food Challenges ◽  
Hydrolyzed Formula

Background: We sought to determine whether an extensively hydrolyzed formula (EHF) supplemented with two human milk oligosaccharides (HMO) was tolerated by infants with cow’s milk protein allergy (CMPA). Methods: A whey-based EHF (Test formula) containing 2′fucosyl-lactose (2′FL) and lacto-N-neotetraose (LNnT) was assessed for clinical hypoallergenicity and safety. The Control formula was a currently marketed EHF without HMO. Children with CMPA, aged 2 months to 4 years, were assessed by double-blind, placebo-controlled food challenges (DBPCFC) to both formulas, in randomized order. If both DBPCFC were negative, subjects participated in a one-week, open food challenge (OFC) with the Test formula. Symptoms and adverse events were recorded. Hypoallergenicity was accepted if at least 90% (with 95% confidence intervals) of subjects tolerated the Test formula. Results: Of the 82 children with CMPA that were screened, 67 (intention-to-treat [ITT] cohort—mean age 24.5 ± 13.6 months; range 2–57; 45 [67.2%] male) were randomized to receive either the Test or the Control formula during the first DBPCFC. Of these, 64 children completed at least one DBPCFC (modified intention-to-treat [mITT] cohort). Three children were excluded due to protocol deviations (per protocol [PP] cohort; n = 61). There was one allergic reaction to the Test, and one to the Control formula. On the mITT analysis, 63 out of 64 (98.4%; 95% CI lower bound 92.8%), and on the PP analysis 60 out of 61 (98.4%; 95% CI lower bound 92.5%) participants tolerated the Test formula, confirming hypoallergenicity. Conclusion: The whey-based EHF supplemented with 2′FL and LNnT met the clinical hypoallergenicity criteria and can be recommended for the management of CMPA in infants and young children.

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