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Food Allergy Fact

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Research Grants

FARE is the largest private source of funding for food allergy research. Below you can read excerpts about FARE’s research grants that are currently underway, as well as details about select completed FARE research grants.

CURRENT RESEARCH GRANTS

Clinical Trials

Wesley Burks, MD

University of North Carolina School of Medicine, Chapel Hill, NC
Oral immunotherapy for peanut-allergic patients

According to a major national prevalence study funded by FARE, peanut allergy is the most common food allergy in U.S. children. Oral immunotherapy (OIT) may prevent life-threatening reactions in these children.  During OIT, patients ingest small but steadily increasing doses of a food allergen until they are sensitized to that food. The ultimate goal is to teach the person’s immune system to tolerate the allergen.

Dr. Burks’ study has two aims. First, he and his team will use peanut OIT to lower the risk of anaphylactic reactions by raising the threshold needed to cause an allergic reaction.  Second, they want to determine whether or not this new treatment can permanently change the peanut-specific immune response in peanut-allergic patients.  Early results suggest that most children can be desensitized to peanuts if they respond well to the initial treatment.  This data also shows that the immunologic changes are significant.  However, the development of long-term tolerance is still under active investigation.  It is important to note that, while this treatment is promising, additional studies must be conducted before it is ready for clinical use.

Wesley Burks, MD

University of North Carolina School of Medicine, Chapel Hill, NC
Peanut Sublingual Immunotherapy Trial

Dr. Burks’ previous studies on sublingual immunotherapy (SLIT) and oral immunotherapy (OIT) for peanut have shown that both approaches are able to desensitize most patients to a degree that is likely to prevent allergic reactions after accidental ingestion. However, while SLIT appears to be far safer than OIT, it produces a less robust desensitization effect. The long-term objective of this study is to develop a safe and effective treatment for peanut allergy that will enable patients to develop tolerance. To that end, this study of 48 patients aims to determine whether 36 months of treatment with peanut SLIT will result in clinical tolerance. It also seeks to define the changes in the body’s immune system that lead to tolerance. Dr. Burks and his team hope that this study will provide a strong scientific basis for the development of SLIT and other treatments that aim to produce long-term clinical tolerance to peanuts and other foods.

Stacie Jones, MD

Arkansas Children’s Hospital, Little Rock, AR
Walnut oral immunotherapy in tree nut-allergic children and adults

Patients with tree nut allergy are typically allergic to multiple tree nuts (walnuts, almonds, cashews, etc.) and most retain their allergy for a lifetime. The participants in this study are allergic to walnut and at least one other tree nut.  Dr. Jones and her team hypothesize that walnut oral immunotherapy (OIT) will reduce the severity of these patients’ response to multiple tree nuts (desensitization).  This study seeks to answer three questions:

  • Can walnut protein OIT desensitize patients to walnut?
  • Can walnut protein OIT desensitize patients to other tree nuts?
  • Does this therapy promote tolerance—that is, can it produce changes in the immune system that might allow patients to safely eat problem foods, even after treatment is discontinued? 

Gideon Lack, MBBCh, FRCPCH

King’s College London, UK
Tolerance to peanut in high-risk children (LEAP Study)

The LEAP (for “Learning Early About Peanut Allergy”) study is co-funded by the National Institutes of Health (NIH) and FARE. Dr. Lack and his team want to determine whether or not exposure to peanuts early in life can prevent the development of peanut allergy.  Over the past several decades, faced with the growing problem of peanut allergy, health authorities in the UK, Canada, the United States and others have laid out recommendations that children at high risk for peanut allergy who are under the age of three should not eat any peanut-containing foods. More recently, however, scientists have begun calling this strategy into question. They now hypothesize that by repeatedly exposing a child's immune system to peanut at an early age, the body may learn to tolerate peanut proteins (allergens). If this theory is correct, these children would not experience allergic reactions during their toddler years.

To determine the best strategy to prevent peanut allergy in young children, the LEAP study will compare peanut avoidance versus peanut consumption in a population of high-risk children. By May 2009, the study had achieved its target enrollment: 640 infants, aged 4–11 months, with severe eczema, egg allergy or both. These children were randomly assigned to receive a peanut-containing snack or to avoid peanut until 60 months of age. The LEAP team anticipates that the study will reach completion in early 2014. At that time, the prevalence of peanut allergy will be compared between the two groups, and the results will be analyzed and published.

Xiu-Min Li, MD

Mount Sinai School of Medicine, New York, NY
Therapeutic effect of Chinese herbal medicine (Food Allergy Herbal Formula 2) on food allergy

Traditional Chinese Medicine (TCM) has a long history of human use in China and other Asian countries and is beginning to play a role in healthcare in the U.S. There is also increasing scientific evidence demonstrating the safety and efficacy of TCM for allergic diseases.  With funding from FARE and the National Institutes of Health (NIH), Dr. Xiu-Min Li and her team are developing a potential new therapy, based on TCM, which may prevent anaphylactic reactions in food-allergic patients. 

Food Allergy Herbal Formula-2 (FAHF-2) is derived from a classic herbal formula, Wu-Mei-Wan, which has been used in TCM for treating parasite infections and symptoms of food allergy-like conditions.  Preclinical studies showed that FAHF-2 was safe and that it completely prevented peanut anaphylaxis in an animal model of peanut allergy. Research also showed that FAHF-2 curbed the activity of specific cells that play a role in the inflammatory process, and that this therapy was effective in treating multiple food allergies.

Based on this information, FAHF-2 entered clinical trials as a U.S. FDA Investigational New Drug (IND).  Dr. Li and her team are now conducting a Phase 2 clinical trial, which is testing the effectiveness and safety of FAHF-2 in patients with peanut and/or tree nut, fish, shellfish, and sesame allergies. Participants in this trial receive a new formulation of FAHF-2, which reduces the dosage from 30 tablets per day to eight tablets. The study is underway at three centers: Mount Sinai, Arkansas Children’s Hospital Research Institute (Little Rock, AR), and Lurie Children’s Hospital (Chicago, IL).

Kari Nadeau, MD, PhD

Stanford University, Stanford, CA
Multiple food allergen oral immunotherapy

Thirty percent of food-allergic children suffer from more than one food allergy, and those with multiple food allergies are three times more likely to have severe food allergy.  Multiple food allergies also pose greater economic, nutritional and social burdens on patients and their families.

Several studies have been performed and are ongoing to evaluate the effectiveness of oral immunotherapy (OIT) for single food allergies, including milk, egg and tree nut allergy. These protocols take many months or years, and consecutive administration of food allergens in a single step-by-step fashion is cumbersome.  Studies specifically evaluating OIT to multiple food allergens have not yet been performed to address this important need. 

The concept of simultaneous introduction of multiple offending allergens is not new. Subcutaneous multiple allergen immunotherapy (“allergy shots”) has been safely and effectively used for environmental allergens, such as hay fever, for more than a century.

The long-term goal of Dr. Nadeau’s study is to develop a safe, effective, protective—and potentially curative—treatment for people with multiple food allergies. Participants follow a customized regimen of OIT for multiple foods simultaneously. Treatment is based on each patient’s specific, rigorously characterized sensitivities. Dr. Nadeau and her team also will evaluate specific immune mechanism(s) which, they believe, will contribute to and indicate the long-lasting effects of OIT. These laboratory evaluations may help clinicians to monitor and predict the safety and effectiveness of OIT.

Hugh A. Sampson, MD

Icahn School of Medicine at Mount Sinai, New York, NY
Oral immunotherapy combined with humanized monoclonal anti-IgE antibody (omalizumab) in the treatment of cow’s milk allergy

Milk allergy is the most common cause of food allergy in infants and young children, and usually develops in the first year of life. Several studies have suggested that milk-allergic children who receive milk protein oral immunotherapy (OIT) may become desensitized to milk, resulting in short-term protection against accidental ingestion of milk products. However, these children did not develop "tolerance"—long-term protection even after milk immunotherapy is stopped.

Dr. Hugh Sampson and his team are trying to learn if combining Xolair® (omalizumab) with milk OIT will be safer and more effective than OIT alone in inducing tolerance—not just desensitization—to milk.  Xolair, an asthma medication, may reduce allergy symptoms by attaching itself to IgE, the major antibody that triggers allergic reactions to food.

At key points in this study, participants will undergo an oral food challenge to determine if they have become desensitized to milk. If so, sometime after stopping treatment, these patients will be tested for tolerance.

The study, which is co-funded by the National Institutes of Health (NIH) and FARE, is being conducted at three centers: Mount Sinai, Stanford University School of Medicine (Stanford, CA), and Johns Hopkins School of Medicine (Baltimore, MD).

Hugh A. Sampson, MD

Icahn School of Medicine at Mount Sinai, New York, NY
Oral Immunotherapy for wheat allergy

Wheat is a common cause of food allergy in infancy and childhood. Since wheat is widely used in westernized diets, strict avoidance is very common and accidental ingestions are frequent. Studies of oral immunotherapy (OIT) for milk, egg, and peanut allergy have shown promising results, although adverse reactions are not infrequent. This study is evaluating the safety and effectiveness of OIT for wheat allergy. Four centers are participating in this study: Mount Sinai, Johns Hopkins School of Medicine (Baltimore, MD), Lurie Children’s Hospital (Chicago, IL), and Stanford University School of Medicine (Stanford, CA).

Dale Umetsu, MD, PhD

Boston Children’s Hospital/Harvard Medical School, Boston, MA
Peanut Reactivity Reduced by Oral Tolerance in an anti-IgE Clinical Trial (PRROTECT)

The goal of the PRROTECT study is to develop a safe and effective oral immunotherapy (OIT) for patients with peanut allergy. The study hypothesis is that combining peanut OIT with Xolair will facilitate fast, safe, and effective oral desensitization. Four sites are participating in this study of 36 patients: Boston Children’s Hospital/Harvard Medical School; Children’s Hospital of Philadelphia/University of Pennsylvania; Stanford University School of Medicine (Stanford, CA); and Lurie Children’s Hospital/Northwestern University (Chicago). The study is supported by FARE and by Genentech, as well as numerous donors and families in Boston, Stanford, Philadelphia and Chicago.

Robert A. Wood, MD

Johns Hopkins University, Baltimore, MD
Safety and efficacy of oral and sublingual immunotherapy in children with persistent peanut allergy

Previous studies have shown that both sublingual (SLIT) and oral (OIT) immunotherapy are promising treatments for peanut allergy. However, additional studies are needed to further evaluate the safety and effectiveness of these therapies, and to understand the mechanisms of desensitization and tolerance.

During SLIT, the food allergen is administered under the tongue. During OIT, patients ingest the allergen, which is administered as a powder that is mixed with a harmless food. Dr. Wood and his team hypothesize that peanut-allergic children can be desensitized after they receive a course of SLIT with peanut extract and OIT with peanut flour. Desensitization would protect these children from life-threatening reactions. Further, the researchers believe that some participants will achieve tolerance, which would allow them to introduce peanuts to their diet. Finally, laboratory analysis will increase our understanding of the immunological changes that lead to desensitization and tolerance.

Data Administration and Analysis

Ruchi S. Gupta, MD, MPH

Northwestern University Feinberg School of Medicine/Lurie Children’s Hospital, Chicago, IL
Food allergy manuscript development

Over the course of two years, Dr. Ruchi Gupta, key collaborators, research associates, and a biostatistician will launch a concerted effort to retrieve data from the Children’s Memorial Food Allergy Study. This unique database contains survey data, skin testing, and blood collection from parents, siblings and children with food allergies.

Dr. Gupta and her colleagues will conduct background literature reviews, perform statistical analyses and draft manuscripts for eight papers on important topics that will contribute to our understanding of food allergies.  Abstracts will be submitted for presentation at the annual conferences of the American Academy of Allergy, Asthma & Immunology (AAAAI) and the Pediatric Academic Society. Manuscripts will be submitted to key academic journals, including the Journal of the American Medical Association, Pediatrics, and the Journal of Allergy and Clinical Immunology.

Dr. Gupta’s work is part of a larger effort, headed by Dr. Xiaobin Wang and funded by FARE, to build a research consortium that mines data from the Children’s Memorial Study.

Xiaobin Wang, MD, ScD, MPH

Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD
Data administration and analysis core

This FARE-funded project is a collaboration between the Johns Hopkins University Bloomberg School of Public Health (Baltimore, MD) and Lurie Children’s Hospital/Northwestern University Feinberg School of Medicine (Chicago, IL). These institutions have formed a consortium that conducts research and publishes manuscripts on food allergy, using data mined from the Children’s Memorial Food Allergy Study. This study draws on data from three cohorts, comprising approximately 1300 families:

  • Chicago Family Cohort: 1,000 families (biologic parents and food-allergic child)
  • Boston Birth Cohort: 6,500 mother-infant pairs
  • Chinese Twin Cohort: 2,000 twin pairs

A crucial objective is to generate the preliminary data needed to apply for grants from the National Institutes of Health (NIH). The overarching goal of this project is to discover the genetics, gene-environmental interactions, and epigenetic causes of food allergies. This data will advance the effort to prevent or cure this potentially life-threatening medical condition.  

Immunology

Simon G.A. Brown, MD

Western Australian Institute for Medical Research, Perth, Australia
Leukocyte signaling during human anaphylaxis

Understanding the mechanisms of anaphylaxis is critical to developing treatments and preventive strategies for food allergy. Dr. Simon Brown and his team are studying how the immune system is activated during this severe reaction to food. 

The researchers will use a genome-wide approach to identify factors that contribute to the severity and clinical symptoms of anaphylaxis. By analyzing blood samples from patients who were treated in the emergency department over time, they hope to define the molecular pathways that are activated during anaphylaxis, and more importantly, the sequence in which this occurs. 

In a 2006 study, Dr. Brown defined which cytokines—messenger proteins produced by cells—are involved in human anaphylaxis.  Based on their findings, he and his team hypothesized that leukocytes (white blood cells) may be a key part of the early inflammatory process that converts mild reactions into severe ones. The researchers hope to prove this theory by studying the genes that are activated very early during a severe anaphylactic reaction (on arrival in the Emergency Department), measuring how the activation of other genes proceeds over the next few hours, and correlating this with the concentrations of inflammatory substances in the blood.

Fred Finkelman, MD

University of Cincinnati College of Medicine/Cincinnati Children’s Hospital Medical Cente
Rapid suppression of food allergy with anti-FceRI antibody

Dr. Finkelman and his team are developing a potential new therapy that could rapidly and safely suppress food allergies. They have developed a monoclonal antibody, a special type of antibody that is grown in the laboratory. The monoclonal antibody targets specific cells that are responsible for the symptoms of a food allergy reaction. It deactivates these cells, making them harmless. In a previous study, the researchers were able to suppress food allergies in mice over a period of weeks. Their FARE-funded study will enable them to continue their work in mouse models with the goal of adapting the treatment to humans and making it work faster -- possibly within 24 hours. If successful, this treatment could be applied to all food allergies, and possibly to other allergic diseases, such as skin allergies. This treatment would be especially beneficial to individuals with difficult-to-treat multiple food allergies, since it would allow physicians to desensitize these patients to all of their allergens at the same time. If this study is successful, the next step will be testing in a primate model, which could lead to a Phase 1 clinical trial in humans.

Registries and Repositories

Hugh A. Sampson, MD, and Scott H. Sicherer, MD

Mount Sinai School of Medicine, New York, NY
Food Allergy Resource Initiative (FARI)

The Food Allergy Resource Initiative (FARI) is a library of crucial resources for scientists who are conducting food allergy studies. FARI’s purpose is two-fold: (1) to establish the Food-Allergic Disorders Serum Bank and Registry, a repository of serum samples from patients who have been confirmed to have food allergies; and (2) to establish the DNA Food Allergen Repository, which contains complementary DNAs (cDNAs) for the proteins in all major food allergens.  FARI investigators are able to reproduce large quantities of allergenic proteins from the cDNAs. In turn, the proteins are used to develop new diagnostic methods and therapies. These resources are available, free of charge, to any investigator who submits a research protocol that is approved by the Food Allergy Repository Advisory Board.

AAAAI/FARE Howard J. Gittis 3rd/4th Year Fellowship/Junior Faculty Research Award

Emily McGowan, MD

Johns Hopkins University School of Medicine, Baltimore, MD
Folic Acid Supplementation: A Risk Factor for the Development of Food Allergy?

Dr. McGowan is examining whether folic acid supplementation, either in utero or in early life, is a risk factor for the development of food allergy. She and her team chose to examine folic acid because food allergies started to become more common in the 1990s, which corresponds to when folic acid was added to grains/cereals and was recommended as a pregnancy supplement to prevent neural tube defects (birth defects of the brain, spine or spinal cord) in newborns. From a scientific standpoint, folic acid is also known to change the expression of certain genes, which may contribute to the development of food allergy. If folic acid proves to be a risk factor for developing food allergies, researchers could target safe folic acid levels to both prevent neural tube defects and minimize the risk of developing food allergy in future generations. If investigators find that only certain individuals are at risk for this folic acid effect, intervention would be limited to those at increased risk.

Select Completed Grants

Described below are a selection of FARE-funded studies that are notable for their impact on the field or that provide particularly valuable information for individuals and families who are living with food allergies.

Paul J. Bryce, PhD

Northwestern University Feinberg School of Medicine, Chicago, IL
Rapid Induction to Tolerance of Food Allergens
Published in The Journal of Immunology, October 2011

Dr. Paul Bryce, a food allergy expert, and Dr. Stephen Miller, an immunobiologist, have developed a therapy that successfully “turns off” the life-threatening allergic response to peanuts in mice. This approach, known as antigen-specific tolerance therapy, has been effective in treating mouse models of multiple sclerosis and type 1 diabetes. This was the first time that it was tested in allergic diseases. Preliminary data suggests that this approach also may work in asthma.

To make the mice tolerant to peanut, the researchers attached peanut proteins onto blood cells called leukocytes and reintroduced them to the body. Simply put, this method tricks the immune system into thinking that the nut proteins are not a threat to the body. Ultimately, it may be possible to target multiple food allergies at one time by attaching more than one protein to the surface of the cell.

It is important to note that more research is needed before this method can be tested in humans. If future studies prove successful, however, this research could lead to new immunotherapies for food allergies.

The study was funded by FARE and the National Institutes of Health (NIH).

Read the abstract of this study>


Ruchi S. Gupta, MD, MPH

Northwestern University Feinberg School of Medicine/Lurie Children’s Hospital, Chicago, IL
Geographic variability of childhood food allergy in the United States
Published in Clinical Pediatrics, September 2012

Children living in urban centers have a much higher prevalence of food allergies than those living in rural areas, according to this FARE-funded study conducted by Dr. Ruchi Gupta and colleagues. In particular, children in large cities are more than twice as likely to have peanut and shellfish allergies compared to those in rural communities. This data suggests that environmental factors play a role in the development of food allergy. 

The results of the study – the first to map children’s food allergies by geographical location in the United States – were published in the September 2012 issue of Clinical Pediatrics. The study included 38,465 children, 18 years and under, who comprised a representative sample of U.S. households. Their food allergies were mapped by ZIP code. Key findings include:

  • In urban centers, 9.8 percent of children have food allergies, compared to 6.2 percent in rural communities, almost a 3.5 percent difference.
  • Peanut allergies are twice as prevalent in urban centers as in rural communities, with 2.8 percent of children having the allergy in urban centers compared to 1.3 percent in rural communities. Shellfish allergies are more than double the prevalence in urban versus rural areas: 2.4 percent of children have shellfish allergies in urban centers compared to 0.8 percent in rural communities.
  • Food allergies are equally severe regardless of where a child lives.
  • The states with the highest overall prevalence of food allergies are Nevada, Florida, Georgia, Alaska, New Jersey, Delaware, Maryland and the District of Columbia.

The study controlled for household income, race, ethnicity, gender and age. It tracked food allergy prevalence in urban centers, metropolitan cities, urban outskirts, suburban areas, small towns and rural areas.

Read the full study>

Understanding the prevalence of childhood food allergy in the United States
Published in Pediatrics, July 2011

This national survey of 38,480 families was the largest study ever conducted on the prevalence of food allergies in U.S. children. Dr. Ruchi Gupta and colleagues collected extensive information on each food allergy reported, including date of onset, method of diagnosis, and reaction history. Data on race and ethnicity, gender, socioeconomic status, and geographic region were also collected.

Key findings include:

  • An estimated 5.9 million U.S. children – eight percent, or roughly two in every classroom – have a food allergy
  • 38.7 percent of the children in the survey had a severe or life-threatening allergy
  • 30.4 percent had multiple food allergies
  • Children with food allergies were most commonly allergic to peanuts (25.2 percent), milk (21.1 percent) and shellfish (17.2 percent), followed by tree nuts (13.1 percent), and egg (9.8 percent)
  • Severe reactions were most common among children with a tree nut, peanut, shellfish, soy, or fin fish allergy
  • Children aged 14-17 years were most likely to have a severe food allergy
  • Food allergies affect children in all geographic regions
  • Asian and African American children were more likely to have a convincing history of food allergy, but were less likely to receive a formal diagnosis when compared to white children

Read the full study>


Scott H. Sicherer, MD, PhD

Mount Sinai School of Medicine, New York, NY
Prevalence of peanut and tree nut allergy in the United States determined by a random-dial telephone survey: a third 11-year follow-up study  (1997-2008)
Published in the Journal of Allergy and Clinical Immunology, June 2010

Prevalence studies pinpoint how many people in a population have a specific disease at a given time. This was the third of three studies, conducted at five-year intervals by Dr. Scott Sicherer and colleagues, which examined the prevalence of peanut and tree nut allergy in the United States. In the U.S., peanut and tree nut are among the most common causes of fatal and near-fatal reactions to food. The results of all three studies were published in the Journal of Allergy and Clinical Immunology (JACI).

In 1997, following their first national phone survey, the researchers concluded that peanut and tree nut allergies represented “a significant health concern.” The follow-up study, conducted in 2002, showed that the rate of peanut and tree nut allergies had not increased significantly in adults. However, peanut allergy had doubled among children during the past five years. Subsequent studies in the United Kingdom and Canada also showed a high prevalence of peanut allergy in schoolchildren

With the passage of another five years, Dr. Sicherer and his colleagues used the same methodology as in the previous studies to take another look at the prevalence of peanut and tree nut allergies in the U.S. They surveyed 5,300 households — more than 13,500 individuals — and compared the results to the earlier surveys. Among other important data, this follow-up study, published in JACI in June 2010, showed that, while peanut and tree nut allergies continued to remain steady among adults, peanut allergy in children more than tripled from 1997 to 2008. The rate of childhood tree nut allergy also increased, from 0.2% in 1997 to 1.1% in 2008.

Both this study and the 2002 project were funded by FARE; the most recent study was co-funded by the National Institutes of Health (NIH).

Read the abstract of this study>

Peanut allergen exposure through saliva: Assessment and interventions to reduce exposure
Published in the Journal of Allergy and Clinical Immunology, September 2006

Dr. Scott Sicherer and colleagues undertook a study to investigate how long peanut protein typically remains in saliva after a meal of peanut butter, and to develop ways to efficiently remove residual peanut protein from the mouth. They found that peanut residue gradually disappeared from the mouth, reaching undetectable levels if participants waited a few hours and had a peanut-free meal. The researchers also tested five methods to remove peanut butter, such as brushing teeth and chewing gum. These methods generally reduced the peanut to levels that were unlikely to cause a reaction. However, some peanut was still detectable in several of the 30 participants. The researchers concluded that peanut-allergic patients require counseling regarding the risks of kissing or sharing utensils.

Read the abstract of this study>