IgE Threshold Testing for Food Allergy
Recruiting in Palo Alto (17 mi)
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Must not be taking: Beta-blockers, Omalizumab, Dupilumab
Disqualifiers: Pregnancy, Cardiac disease, Eosinophilic GI, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?
Background: Atopic dermatitis (AD), also called eczema, makes skin dry, red, and itchy. People with AD are more likely to get a food allergy than people without AD. But some food allergy tests are not always accurate in people with AD. Researchers want to study if people are truly allergic to milk and/or peanuts. Objectives: To improve the ways doctors test for food allergy in people with AD. Eligibility: People ages 3 21 who have had AD; have a high total IgE level (an allergic antibody); might have a milk and/or peanut allergy; and are currently enrolled in another NIH study Design: Participants will be screened under another protocol. Participants will have a physical exam, blood tests, and medical history. Participants will breathe into a plastic device that measures lung strength. Participants may get a small plastic tube inserted in their arm. Participants who have not had an allergic reaction to food in the past 3 years will do 1 or more oral food challenge (OFCs) depending on their allergies. They will eat a little bit of the food they might be allergic to. They will be watched for a reaction. If they have one, they will know for sure they are allergic. They may keep eating bigger portions of the food until they either have a reaction or finish all the food. In some OFCs, participants will get a placebo food. OFCs will last a few hours or 2 days. Participants will repeat all tests at each OFC. Participation can last up to 12 months. ...
Will I have to stop taking my current medications?
You may need to stop taking certain medications like omalizumab or dupilumab at least 6 months before a food challenge, and you might need to stop antihistamines and oral steroids before the challenge as well. However, you can continue using topical steroids.
What data supports the effectiveness of the treatment Baked milk and Rice milk (placebo for Baked milk), Baked milk, Heated milk, Rice milk (as placebo), Dry Milk Powder and Corn Starch (placebo for Milk powder), Dry Milk Powder, Milk Powder, Corn Starch (placebo), Peanut flour and Oat flour (placebo for peanut flour), peanut flour, oat flour (placebo), Peanut powder and Oat flour, Peanut powder: Arachis hypogaea, Groundnut powder; Oat flour: Avena sativa flour for food allergy?
Is there safety data for IgE Threshold Testing for Food Allergy treatments like Baked milk, Rice milk, and Peanut flour?
Research shows that peanut allergen powder used in oral immunotherapy has been evaluated for safety in clinical trials, indicating it is generally safe for use in humans. However, hypoallergenic milk substitutes may contain aflatoxin, a potential contaminant, so control measures should be in place to ensure safety.678910
How does IgE Threshold Testing for Food Allergy differ from other treatments for food allergies?
IgE Threshold Testing for Food Allergy is unique because it focuses on determining the specific level of IgE antibodies (immune system proteins that react to allergens) that trigger allergic reactions, which can help tailor dietary recommendations and predict safe food consumption, unlike standard treatments that often involve complete avoidance of allergens.18111213
Eligibility Criteria
This trial is for children and young adults aged 3-21 with atopic dermatitis (eczema) who may have milk or peanut allergies, a high total IgE level, and are part of another NIH study. They must be willing to stop certain allergy medications before food challenges.Inclusion Criteria
You have been diagnosed with Alzheimer's disease by a doctor or you have reported having symptoms of Alzheimer's disease.
I am willing to have genetic tests done on my blood.
Willing to allow storage of blood samples for future use in medical research.
See 7 more
Exclusion Criteria
I have a known heart condition.
I am on long-term oral steroids for a chronic condition.
I am currently taking a beta-blocker medication.
See 5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Oral Food Challenge
Participants undergo open feedings and/or double-blind, placebo-controlled food challenges to assess food allergies
Up to 12 months
Multiple visits for each food challenge
Follow-up
Participants are monitored for safety and effectiveness after food challenges
4 weeks
Treatment Details
Interventions
- Baked milk and Rice milk (placebo for Baked milk) (Other)
- Dry Milk Powder and Corn Starch (placebo for Milk powder) (Other)
- Peanut flour and Oat flour (placebo for peanut flour) (Other)
- Peanut powder and Oat flour (Other)
Trial OverviewThe trial tests if participants with eczema are truly allergic to milk or peanuts by giving them increasing amounts of these foods or placebos in controlled settings. The goal is to improve food allergy testing methods.
Participant Groups
4Treatment groups
Experimental Treatment
Group I: Two-Step Open FeedingExperimental Treatment4 Interventions
Participants who consume baked milk, straight milk, and/or peanut products less than once per week but at least once per month will do a two step open oral food challenge.
Group II: Peanut DBPCFCExperimental Treatment2 Interventions
The DBPCFC for peanut allergy will be done with either peanut flour or a placebo (oat flour). The following participants will undergo this DBPCFC: - All participants who eat peanut less than once per month - Participants who never eat peanut On the first day of this challenge, participants will be randomized to either peanut or placebo, and then will be challenged with the other food on the next day.
Group III: One-Step Open FeedingExperimental Treatment4 Interventions
Participants who are consuming baked milk, straight milk, and/or peanut products at least once per week will do a one-step oral food challenge.
Group IV: Milk DBPCFCExperimental Treatment2 Interventions
There are two double blind placebo controlled food challenges. The first challenge is to baked milk. The following participants will undergo this DBPCFC: - All participants who eat baked milk less than once per month. - Participants who never eat baked milk or straight milk. On the first day of this challenge, participants will be randomized to either milk Baked milk or rice milk. Dry milk powder or corn starch. or placebo, and then will be challenged with the other food on the next day.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
National Institutes of Health Clinical CenterBethesda, MD
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Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
National Institutes of Health Clinical Center (CC)Collaborator
References
Prospective evaluation of testing with baked milk to predict safe ingestion of baked milk in unheated milk-allergic children. [2020]Cow's milk allergy is one of the most common food allergies affecting young children. A subset of milk-allergic individuals can eat baked milk without allergic symptoms which is beneficial in terms of prognostication and liberalization of the diet. A retrospective study suggested that skin prick testing (SPT) with a baked milk (muffin) slurry may provide a sensitive means of predicting the outcome of a medically supervised baked milk oral food challenge. We evaluated the predictive value of SPT with baked milk to identify unheated milk-allergic children who are able to safely eat baked milk.
Benefits of baked milk oral immunotherapy in French children with cow's milk allergy. [2021]Introduction and gradual incremental escalation of a low dose of baked milk may accelerate the resolution of severe cow's milk (CM) allergy for some children. The purpose of our study was to evaluate the efficacy and safety of baked milk oral immunotherapy (OIT) in children with CM allergy after a low-dose baked milk oral food challenge (OFC).
Matrix effect on baked milk tolerance in children with IgE cow milk allergy. [2017]Children with IgE-mediated cow's milk allergy (IgE-CMA) often tolerate baked milk within a wheat matrix. In our study we evaluated the impact of wheat matrix and of little standardised cooking procedures on tolerance of baked milk. We also tested tolerance versus parmigiano reggiano (PR) and whey-based partially hydrolysed formula (pHF).
New approach for food allergy management using low-dose oral food challenges and low-dose oral immunotherapies. [2022]A number of studies have suggested that a large subset of children (approximately 70%) who react to unheated milk or egg can tolerate extensively heated forms of these foods. A diet that includes baked milk or egg is well tolerated and appears to accelerate the development of regular milk or egg tolerance when compared with strict avoidance. However, the indications for an oral food challenge (OFC) using baked products are limited for patients with high specific IgE values or large skin prick test diameters. Oral immunotherapies (OITs) are becoming increasingly popular for the management of food allergies. However, the reported efficacy of OIT is not satisfactory, given the high frequency of symptoms and requirement for long-term therapy. With food allergies, removing the need to eliminate a food that could be consumed in low doses could significantly improve quality of life. This review discusses the importance of an OFC and OIT that use low doses of causative foods as the target volumes. Utilizing an OFC or OIT with a low dose as the target volume could be a novel approach for accelerating the tolerance to causative foods.
Introduction of Heated Cow's Milk Protein in Challenge-Proven Cow's Milk Allergic Children: The iAGE Study. [2022]The introduction of baked milk products in cow's milk (CM) allergic children has previously been shown to accelerate induction tolerance in a selected group of children. However, there is no standardized baked milk product on the market. Recently, a new standardized, heated and glycated cow's milk protein (HP) product was developed. The aim of this study was to measure safety and tolerability of a new, well characterized heated CM protein (HP) product in cow's milk allergic (CMA) children between the age of 3 and 36 months. The children were recruited from seven clinics throughout The Netherlands. The HP product was introduced in six incremental doses under clinical supervision. Symptoms were registered after introduction of the HP product. Several questionnaires were filled out by parents of the children. Skin prick tests were performed with CM and HP product, sIgE to CM and α-lactalbumin (Bos d4), β-lactoglobulin (Bos d5), serum albumin (Bos d 6), lactoferrin (Bos d7) and casein (Bos d8). Whereas 72% percent (18 out of 25) of the children tolerated the HP product, seven children experienced adverse events. Risk factors for intolerance to the HP product were higher skin prick test (SPT) histamine equivalent index (HEP) results with CM and the HP product, higher specific IgE levels against Bos d4 and Bos d8 levels and Bos d5 levels. In conclusion, the HP product was tolerated by 72% of the CM allergic children. Outcomes of SPT with CM and the HP product, as well as values of sIgE against caseins, α-lactalbumin, and β-lactoglobulin may predict the tolerability of the HP product. Larger studies are needed to confirm these conclusions.
Participant characteristics and safety outcomes of peanut oral immunotherapy in the RAMSES and ARC011 trials. [2022]Clinical trials (PALISADE [ARC003], ARTEMIS [ARC010]) proving efficacy and safety of peanut (Arachis hypogaea) allergen powder-dnfp (PTAH) have used double-blind, placebo-controlled food challenges (DBPCFCs) to screen for eligibility and to evaluate efficacy. In routine clinical practice, individuals with peanut allergy do not always undergo food challenges to confirm diagnosis or determine candidacy for treatment.
Occurrence of Aflatoxin in Hypoallergenic Milk Substitutes. [2023]Aflatoxin B1 was detected, and its identity confirmed, in hypoallergenic milk substitutes composed, among other things, of the following ingredients susceptible to possible aflatoxin contamination: soya protein isolate, soy and coconut oils, cornstarch, and corn syrup. Except for one determination all findings were under 1 ng of aflatoxin/ml of formula at drinking concentration. Manufacturers' reserve samples of soya protein isolate, the ingredient thought to be the most likely source of the aflatoxin, were found to be uncontaminated. Reserve samples of other ingredients were not examined. Because hypoallergenic formula may be the major nutrient of an individual with a metabolic defect at infancy, a vulnerable stage of life, available control measures should be used to avoid aflatoxin-contaminated ingredients.
Farm animal feeders: another group affected by cereal flour asthma. [2019]Asthma induced by cereal flour is a long recognized entity. We present studies of three patients affected by asthma related to exposure to cereal flour contained in animal formula feeds. Skin prick test performed with the formula feed components showed positive reactions to cereal flours (wheat, rye and barley) and negative to the other substances in these formulas. Specific anti-wheat, rye and barley flour IgE antibodies were found by RAST. Bronchial provocation tests (BPT) with wheat flour (patients 1 and 2) and barley flour (patient 3) all showed immediate responses. These findings suggest that our patients' symptoms were caused by an IgE-mediated hypersensitivity to cereal flours from animal formula feeds. We call attention to the importance of cereal flours in animal formula feeds as a cause of occupational asthma in farm and animal feeders.
A case of rice allergy in a patient with baker's asthma. [2015]A case of rice allergy in a patient with bakers asthma is described. On ISAC 112 IgE reactivity to wheat alpha-amylase/trypsin inhibitor (nTri a aA_TI) and lipid tranfer protein (rTri a 14) was found. We hypothesize that the reaction by oral ingestion was elicited by homologous molecules in rice seeds.
Manufacturing processes of peanut (Arachis hypogaea) allergen powder-dnfp. [2022]Label="Background" NlmCategory="UNASSIGNED">Important components of drug safety, efficacy, and acceptability involve manufacturing and testing of the drug substance and drug product. Peanut flour sourcing/processing and manufacturing processes may affect final drug product allergen potency and contamination level, possibly impacting drug safety, quality, and efficacy. We describe key steps in the manufacturing processes of peanut (Arachis hypogaea) allergen powder-dnfp (PTAH; Palforzia®), a drug used in oral immunotherapy (OIT) for the treatment of peanut allergy.
IgE-mediated allergy to corn: a 50 kDa protein, belonging to the Reduced Soluble Proteins, is a major allergen. [2019]Although corn is often cited as an allergenic food, very few studies have been devoted to the identification of corn allergens and corn allergy has been rarely confirmed by double-blind, placebo-controlled food challenge (DBPCFC). Recently, Pastorello et al. (1) identified some salt-soluble IgE-binding proteins of corn flour as potential allergens. One of these, corresponding to corn Lipid Transfer Protein (LTP), appeared to be the major one. The aim of this study was to verify the clinical significance of the skin prick test (SPT) and CAP-FEIA CAP-System IgE fluozoenzyme immunosorbent assay (Pharmacia Diagnostic, Uppsala, Sweden) positivities to corn and to identify the presence of IgE-binding proteins in the corn flour salt-insoluble protein fractions (comprising up to 96% of the total protein) using sera of patients with DBPCFC-documented food allergy to corn. In addition the effect of cooking and proteolytic digestion on the corn allergens was investigated.
Diagnosis and management of grain-induced asthma. [2021]Grain-induced asthma is a frequent occupational allergic disease mainly caused by inhalation of cereal flour or powder. The main professions affected are bakers, confectioners, pastry factory workers, millers, farmers, and cereal handlers. This disorder is usually due to an IgE-mediated allergic response to inhalation of cereal flour proteins. The major causative allergens of grain-related asthma are proteins derived from wheat, rye and barley flour, although baking additives, such as fungal α-amylase are also important. This review deals with the current diagnosis and treatment of grain-induced asthma, emphasizing the role of cereal allergens as molecular tools to enhance diagnosis and management of this disorder. Asthma-like symptoms caused by endotoxin exposure among grain workers are beyond the scope of this review. Progress is being made in the characterization of grain and bakery allergens, particularly cereal-derived allergens, as well as in the standardization of allergy tests. Salt-soluble proteins (albumins plus globulins), particularly members of the α-amylase/trypsin inhibitor family, thioredoxins, peroxidase, lipid transfer protein and other soluble enzymes show the strongest IgE reactivities in wheat flour. In addition, prolamins (not extractable by salt solutions) have also been claimed as potential allergens. However, the large variability of IgE-binding patterns of cereal proteins among patients with grain-induced asthma, together with the great differences in the concentrations of potential allergens observed in commercial cereal extracts used for diagnosis, highlight the necessity to standardize and improve the diagnostic tools. Removal from exposure to the offending agents is the cornerstone of the management of grain-induced asthma. The availability of purified allergens should be very helpful for a more refined diagnosis, and new immunomodulatory treatments, including allergen immunotherapy and biological drugs, should aid in the management of patients with this disorder.
Immunoglobulin E antibodies to ingested cereal flour components: studies with sera from subjects with asthma and eczema. [2019]The specificity of immunoglobulin E for different cereal grain proteins was investigated using sera from twenty paediatric patients with asthma and/or eczema. Close correlations were observed between radioallergosorbent test values for grain extracts of wheat, rye and barley, and, to a lesser extent, oats. Of the different wheat four fractions tested, the globulins and glutenins consistently bound higher levels of IgE than the gliadins and albumins. This is in contrast both with bakers' asthma (an allergy to inhaled flour where the albumins are important allergens) and with coeliac disease (in which gliadin is the most toxic fraction). Partial digestion of the flour proteins largely removed their ability to bind IgE. An analytical technique of identifying allergens after gel isoelectric focusing demonstrated that many different flour proteins were involved.