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Consensus report from the Food Allergy Research & Education (FARE) 2019 Oral Immunotherapy for Food Allergy Summit
Affiliations.
- 1 Division of Allergy and Immunology, Department of Internal Medicine, University of South Florida Morsani College of Medicine, Tampa, Fla.
- 2 Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
- 3 Medical College of Georgia at Augusta University, Augusta, Ga.
- 4 Food Equality Initiative, Kansas City, Mo.
- 5 Sean N. Parker Center for Allergy and Asthma Research, Stanford University, Stanford, Calif.
- 6 The University of Chicago, Department of Pediatrics, Chicago, Ill.
- 7 University of Iowa Carver College of Medicine, Iowa City, Iowa.
- 8 Center for Food Allergy and Asthma Research, Northwestern University Feinberg School of Medicine, Chicago, Ill; Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Ill.
- 9 FARE (Food Allergy Research & Education), McLean, Va.
- 10 Department of Allergy and Clinical Immunology, Respiratory Institute, Cleveland Clinic, Cleveland, Ohio.
- 11 Gundersen Health System, La Crosse, Wis.
- 12 AllergyStrong, McClean, Va.
- 13 Food Allergy Center, Departments of Pediatrics and Medicine, Massachusetts General Hospital, Boston, Mass.
- 14 the Department of Pediatrics, Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai, New York, NY.
- 15 Food Allergy Center at Emory + Children's, Atlanta, Ga.
- 16 Allergy Partners of North Texas, Dallas.
- 17 Latitude Food Allergy Care, Redwood City, Calif.
- 18 Food Allergy Research & Education (FARE), University of South Florida, Tampa, Fla. Electronic address: [email protected].
- PMID: 32505612
- DOI: 10.1016/j.jaci.2020.05.027
Food allergy is a major health problem affecting 5% to 10% of the population in developed nations, including an estimated 32 million Americans. Despite the large number of patients suffering from food allergies, up until the end of January 2020, no treatment for food allergies had been approved by the US Food and Drug Administration. The only options were avoidance of food allergen triggers and acute management of allergic reactions. A considerable body of data exists supporting oral immunotherapy (OIT) as a promising, novel treatment option, including that for the now Food and Drug Administration-approved peanut OIT product Palforzia (Aimmune Therapeutics, Brisbane, Calif). However, data for long-term quality-of-life improvement with OIT varies, depending on the measures used for analysis. Like many therapies, OIT is not without potential harms, and burdens, and the evaluation of patient-specific risk-benefit ratio of food OIT produces challenges for clinicians and patients alike, with many unanswered questions. Food Allergy Research & Education organized the Oral Immunotherapy for Food Allergy Summit on November 6, 2019, modeled after the PRACTALL sessions between the European Academy of Allergy and Clinical Immunology and the American Academy of Allergy, Asthma & Immunology to address these critical issues. Health care providers, patient representatives, researchers, regulators, and food allergy advocates came together to discuss OIT and identify areas of common ground as well as gaps in existing research and areas of uncertainty and disagreement. The purpose of this article was to summarize that discussion and facilitate collaboration among clinicians and patients to help them make better-informed decisions about offering and accepting OIT, respectively, as a therapeutic option.
Keywords: Food allergy; Oral immunotherapy; Peanut allergy.
Copyright © 2020 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.
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Accidental Reactions in Peanut/Tree Nut Allergic Children
Food allergy is an immune reaction, triggered by food protein allergens, of varying severity, from mild local reaction to life threatening anaphylaxis and fatalities. Peanut is a plant from the botanical family of the Fabaceae, more commonly known as legumes. The prevalence of peanut and tree nut allergy is increasing. In France (ELFE cohort), it is estimated to 0.93%. The tree nuts include mainly almond, hazelnut, pistachio, cashew nut, walnut, pecan nut and Brazil nut. Allergy's prevalence is estimated to 0.54% in children up to 5.5 years. Peanut allergy is a main cause of anaphylaxis and deaths due to food allergy. Recurrence...
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The Anaphylaxis Registry aims to assess data in a standardized form about symptoms, triggers, cofactors and therapy management from patients who experienced an anaphylactic reaction. This should improve diagnosis and long-term management of these life-threatening allergic reactions.
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Research in acute care faces many challenges, including enrollment challenges, legal limitations in data sharing, limited funding, and lack of singular ownership of the domain of acute care. To overcome some of these challenges, the Center of Acute Care of the University Medical Center Groningen in the Netherlands, has established a de novo data-, image- and biobank named "Acutelines". Acutelines is initiated to improve recognition and treatment of acute diseases and obtain insight in the consequences of acute diseases, including factors predicting its outcome. Thereby, Acutelines contributes to development of personalized treatment...
Allergy and Immunology Natural History Study
This protocol is a natural history study designed to evaluate subjects (and some family members) with suspected or identified genetic diseases of allergic inflammation or Immune Dysregulation. Patients determined by clinical history and outside evaluations to be of interest will be consented and enrolled into this study. Blood specimens, stored blood products and derivatives, saliva, hair, fingernail clippings, cord blood, umbilical cord, bone marrow, tissue biopsies and/or buccal swabs from such patients and/or their family members will be obtained for research studies related to understanding genetic and immunopathogenic bases of...
A Multicentre French Prospective Study of Children With Food Protein Induced Enterocolitis Syndrome in Its Acute Form
Food protein induced enterocolitis syndrome (FPIES), is a non-IgE mediated food allergy (FA) which seems to expand, and occurring in infancy. This disease is usually unknown by clinicians. In 2017, an international workgroup of American Academy of Allergy, Asthma and Immunology published clinical criteria to specify the diagnosis. However, there is a lack of information in literature for describe the evolution and atypical phenotypes. In addition, no prospective French series has been published to date. The aim of the study is to collect clinical features and allergy testing of children who have acute form of FPIES at diagnosis and...
Analysing HIgh Dose Probiotic Peanut Oral Immunotherapy (PPOIT) and High Dose Peanut Oral Immunotherapy (OIT) Versus LOw Dose Peanut OIT for Peanut Allergy
This study will compare the effectiveness of three different treatments to treat peanut allergy
An Intervention Study to Improve Therapeutic Compliance in Adult Patients With Eosinophilic Esophagitis.
In many chronic conditions adherence to long-term treatment is a challenge, also for patients with eosinophilic esophagitis. Interventions, such as behavioral, educational and reminder interventions might improve treatment adherence. With this trial the investigators want to assess the effects of additional education in combination with more frequent follow up and patient reminders on adherence to treatment in adult patients with eosinophilic esophagitis.
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A Safety and Efficacy Study of PVX108 in Children and Adolescents With Peanut Allergy
The overall aims of this study are to demonstrate that treatment with PVX108 immunotherapy has an acceptable safety profile and is effective for reducing clinical reactivity to peanut protein in children and adolescents with peanut allergy.
A Study Assessing Esophageal Function and Remodeling With Dupilumab Compared With Placebo for 24 Weeks Followed by 104 Weeks Open Label in Adult Participants With EoE (REMOdeling With Dupilumab in Eosinophilic Esophagitis Long-term Trial)
This is parallel, Phase 4 study which consists of a 24 week (0.5 years) randomized, double blind, placebo controlled, 2-arm treatment period followed by an open label segment of 104 weeks (2 years) for a total of 128 weeks (2.5 years) to evaluate the effect of dupilumab treatment on esophageal function, and remodeling in adults with eosinophilic esophagitis. Duration of study period (per participant) - Screening period: Up to 12 weeks before Week 0 - Randomized double-blind period: 24 weeks - Open label period: 104 weeks - Post Investigational Medicinal Product (IMP) intervention follow-up period: up to...
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Find and learn more about clinical trials.
Clinical trials are studies that determine if a new treatment is safe and effective in people. These research studies are key steps in the approval of new therapies by the U.S. Food and Drug Administration (FDA) . More food allergy clinical trials are underway today than ever before.
Clinical trials are usually conducted at major medical centers. Funding for a study may come from a number of sources, including the federal government’s National Institutes of Health (NIH), nonprofit organizations such as FARE, and pharmaceutical or biotechnology companies.
Participation in a clinical trial is a significant decision for you and your family. To make an informed decision, you’ll want to weigh the benefits and risks of the study you’re considering. You’ll also want to consult your physician, talk to family and friends, and learn all you can.
Reasons to participate in a clinical trial include:
- The opportunity to contribute directly to the search for new treatments and a cure
- The possibility of benefiting from a promising new treatment before it is widely available
- Access to medical care from a team of experts in the field
Find a Clinical Trial
Fare clinical trial finder.
Launched in July 2018, FARE’s online tool simplifies your search for clinical trials to treat food allergy and some related conditions. Compared to the clinicaltrials.gov database maintained by the National Institutes of Health (NIH), the FARE Clinical Trial Finder makes it easier to find relevant clinical trials that are currently recruiting or preparing to recruit patients with food allergy or healthy volunteers who do not have food allergies.
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A service of the National Institutes of Health (NIH), this website is a registry and database of publicly and privately supported clinical studies conducted around the world. The site also includes general information about clinical trials and a glossary of common terms.
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All clinical trials have guidelines about who can participate. These guidelines, or criteria, are used to identify appropriate volunteers and ensure that they can participate safely. The criteria for a particular study may include such factors as age, gender, the type and severity of a disease or condition, previous treatment history, and other medical conditions or complications. Inclusion criteria are the factors that qualify volunteers to participate. Exclusion criteria disqualify people from the study. For food allergy trials, criteria may include the type of food allergy you have, whether or not you have a history of severe reactions or other conditions such as asthma, and so on.
Clinical trials are federally regulated, and strict safeguards are in place to protect participants' safety and ensure confidentiality. Informed consent is an important part of understanding and deciding to participate in a specific study. This process enables potential volunteers to learn the facts about the study before making the decision to participate. Informed consent also ensures that volunteers understand what is happening as the trial progresses.
To help you decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. The informed consent document also explains the trial's benefits (such as the possibility of receiving the treatment after the trial is over, if it proves successful) and risks (such as potential side effects). If you decide to participate, then you sign the document. It is important to remember that informed consent is not a contract - you may withdraw from a clinical trial at any time.
Once you're enrolled in a study, you'll work with a team that includes doctors, nurses, and other health professionals. Team members will give you medical exams and take a detailed medical history at the beginning of the study. They will also monitor you throughout the trial and stay in touch after it is completed.
Keep in mind that participating in a clinical trial does not take the place of ongoing medical care by your primary physician and health care team. If you're thinking of volunteering for a clinical trial, be sure to speak with your doctor before you enroll. In addition, while you are enrolled in the trial, your doctor should be informed of the study's progress.
Clinical trials must meet rigorous safety standards, which are mandated by the federal government. The U.S. Food & Drug Administration (FDA) must approve the study design (also known as the protocol). These are detailed guidelines that describe the objectives and length of the trial, the type of patients who may participate, the schedule of tests and procedures, the medications and dosages to be studied, and so on.
In addition, every medical center has an Institutional Review Board (IRB), which is a panel of scientists and non-scientists that oversees clinical research and is responsible for approving the studies conducted at that institution. The IRB makes sure that the study meets the institution's standards, that participants have given consent to participate and are fully informed of their risks, and that researchers take appropriate steps to protect participants from harm. If the study is a multi-center trial - one that involves several medical centers - each institution's IRB must give its approval.
Before a therapy can be tested in humans, preclinical research is conducted in the laboratory. If these studies show promise, the sponsor - usually a pharmaceutical or biotechnology company or a research institution - requests permission to conduct clinical trials in people by submitting an Investigational New Drug Application (IND) to the FDA. If the FDA approves, the study will be conducted at one or more medical centers (usually large teaching hospitals).
Clinical trials are conducted in four phases:
- Phase 1 clinical trials test the experimental therapy in a small group of people (20-80) to evaluate its safety and identify side effects.
- Phase 2 studies test the therapy in a larger group of patients (100-300) to determine how well the treatment works and to further evaluate safety.
- Phase 3 trials involve a large number of participants (1,000-3,000). These studies confirm the treatment's effectiveness, monitor side effects, compare the experimental treatment to standard therapies, and collect information about safety. Successful completion of a Phase 3 study is usually the final step before the sponsor applies for FDA approval to market the therapy.
- Phase 4 trials are conducted after the treatment is approved by the FDA and marketed to the public. These studies provide more information about a therapy's long-term benefits and risks, its impact on patients' quality of life, its costs relative to its effectiveness, and how it compares to other therapies on the market.
It is important to keep in mind that, at any point in this process, a study may be discontinued if a treatment does not work or has problematic side effects.
If you're considering participating in a clinical trial, it's important that you consult your doctor and other members of your healthcare team first. If you decide to move forward and you meet the initial criteria for the study, you'll be invited to meet with the study's research team. You may want to write down your questions beforehand and bring a friend or relative along to the meeting. Remember, the more you know, the more comfortable you'll feel with your decision. Here is a list of questions that you may find helpful:
- What are the aims of this study?
- How long will the trial last?
- What therapies will be tested and how will they be administered?
- Why do researchers believe the treatment being tested may be effective? Has it been tested before?
- What kinds of tests are involved?
- Could the treatment or tests cause any pain or discomfort?
- Who will be in charge of my care?
- How will participants’ safety be monitored?
- What are the potential benefits and risks? How do they compare with the benefits and risks of my current treatment?
- Who is sponsoring the trial?
- How might this study affect my daily life?
- Do I have to pay for treatment or for any part of the trial? If so, will these expenses be covered by my insurance?
- Will I be reimbursed for non-medical expenses, such as transportation?
- What type of long-term follow up-care is part of this study?
- What happens if I am harmed by the trial?
- Can I opt to remain on this treatment, even after the trial ends?
- How will I know that the experimental therapy is working? Will the study results be provided to me?
For many years, clinical trials were conducted only in adults. To treat children, a common approach has been to use data from adults and adjust the dose of the medication according to a child's weight. But children are not simply small adults. Many factors affect the way they respond to treatments, including the growth and maturation of their organs, changes in metabolism throughout infancy and childhood, and changes in body proportion. In recent years, through a combination of new legislation and incentives for manufacturers, the number of pediatric clinical trials has increased. The FDA applies strict guidelines to children's participation in these studies. For more information, visit the NIH’s Children and Clinical Studies site.
Additional Resources
NIH Clinical Trials and You : An extensive patient-oriented site that offers links to clinical trial registries, educational resources and personal stories.
Children and Clinical Studies : This site, from the NIH National Heart Lung and Blood Institute, explains why clinical trials in children are important and addresses the special needs and concerns of young participants and their families.
NIAID-Funded Food Allergy Research Programs : Learn about programs funded by the National Institute of Allergy and Infectious Diseases (NIAID), the principal NIH institute that supports food allergy research.
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Pollen count and allergy info for Elektrostal'
Elektrostal' pollen and allergy report.
Last update at 06:00, Jun 12 (local time)
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Education. One in 10 Americans has a food allergy, so this disease touches all of us. FARE's goal is to increase public awareness of food allergies while providing trusted resources and community connections to support the 85 million Americans impacted by food allergies and intolerances, including 33 million at risk for life-threatening ...
Our Impact. FARE's mission is to improve the quality of life and health of those with food allergies through transformative research, education, and advocacy. FARE has committed almost $190MM to support food allergy research, education, and advocacy, and has provided a voice for the community, advocating on behalf of the 33 million Americans ...
FARE (Food Allergy Research & Education) is a 501(c)(3) charitable organization with the mission to improve the quality of life and health of those with food allergies through transformative research, education, and advocacy. Read More
FARE (Food Allergy Research & Education) is a 501(c)(3) charitable organization with the mission to improve the quality of life and health of those with food allergies through transformative research, education, and advocacy.
FARE (Food Allergy Research & Education) is a 501(c)(3) charitable organization with the mission to improve the quality of life and health of those with food allergies through transformative research, education, and advocacy. Read More
Data Coordinating Center (DCC) for FARE. The Data Coordinating Center will support critical FARE Clinical Network activities for the design, development, execution, monitoring, and analysis of translational research. If you would like access to this Portal, please email us at [email protected].
Food Allergy Research & Education (FARE) is a non-profit, private organization dedicated to food allergy awareness, research, education, and advocacy. FARE's goal is to enhance the lives of people with food allergies by providing support and resources to help them live safe yet productive lives. FARE also includes information for people without ...
18 Food Allergy Research & Education (FARE), University of South Florida, Tampa, Fla. Electronic address: [email protected]. PMID: 32505612 DOI: 10.1016/j.jaci.2020.05.027 Abstract Food allergy is a major health problem affecting 5% to 10% of the population in developed nations, including an estimated 32 million Americans. ...
FARE (Food Allergy Research & Education) is a 501(c)(3) charitable organization with the mission to improve the quality of life and health of those with food allergies through transformative research, education, and advocacy. Read More
Give parents and students the campus-related food allergy information they need to choose an allergy-friendly college or university. Register today for the Food Allergy Research & Education (FARE)'s College Search to showcase your school's allergy-friendly dining services, housing accommodations, and more.
FARE works on behalf of the 33 million Americans who have food allergies, including all those at ris. Page · Nonprofit organization. Food Allergy Research and Education. is responsible for this Page. 7901 Jones Branch Dr, Ste 240, McLean, VA, United States, Virginia. (703) 691-3179. [email protected]. foodallergy.
Food Allergy Research & Education (FARE), the leading nonprofit organization working on behalf of the 15 million Americans with food allergies, today announced the expansion of the FARE Clinical Network, which now comprises 28 centers of excellence across the country. The FARE Clinical Network, dedicated to changing the face of food allergy care, is the only collaborative network of its kind.
Clinical trials are key steps in the U.S. Food and Drug Administration's drug approval process. Participants can access cutting-edge therapies while playing a vital role in helping researchers develop new treatments. Use the FARE Clinical Trial Finder to simplify your search for research studies that fit your needs: Fill out the filter menu ...
FARE (Food Allergy Research & Education) is a 501(c)(3) charitable organization with the mission to improve the quality of life and health of those with food allergies through transformative research, education, and advocacy. Read More
Elektrostal' pollen count and allergy risks are now 4. Get real-time and forecast pollen count and allergy risks data. Read today's pollen levels in Elektrostal', Moscow Oblast with IQAir.
40 Facts About Elektrostal. Elektrostal is a vibrant city located in the Moscow Oblast region of Russia. With a rich history, stunning architecture, and a thriving community, Elektrostal is a city that has much to offer. Whether you are a history buff, nature enthusiast, or simply curious about different cultures, Elektrostal is sure to ...
Geographic coordinates of Elektrostal, Moscow Oblast, Russia in WGS 84 coordinate system which is a standard in cartography, geodesy, and navigation, including Global Positioning System (GPS). Latitude of Elektrostal, longitude of Elektrostal, elevation above sea level of Elektrostal.
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