Food allergy affects as many as 6% of young children and 3-4% of adults.(1,2) Peanut allergy is the leading cause of food-induced anaphylaxis treated in hospital emergency departments in the United States (3) and peanut and tree nut allergies account for approximately 80% of fatal and near-fatal anaphylactic reactions.(4-6) While the majority of children outgrow their allergy to milk, egg, wheat, and soy, allergies to peanut, tree nuts, fish and shellfish are often life-long. Currently, there are no treatments that can cure or provide long-term remission from food allergy. Traditional Chinese Medicine (TCM) has been used to treat various diseases for thousands of years. Chinese herbal medicine, particularly in the form of formulas that are composed of several herbs, is one of the major components in the practice of TCM. The Food Allergy Herbal Formula (FAHF-2) is a 9 herb formula (7-14) that has been demonstrated to be safe and effective in a murine model of peanut allergy.(15,16) Furthermore, FAHF-2 appears to be safe and well-tolerated in food-allergic patients. This protection from anaphylaxis in the murine model is associated with decreased IgE, increased lgG2a, decreased peripheral basophils, and decreased cell surface expression of FceRI on mast cells and basophils. Thus, we hypothesize that FAHF-2 is a safe and effective herbal therapy for food allergy and this protection is associated with suppression of food specific IgE while increasing food-specific IgG (and lgG4), decreased IgE epitope diversity, and suppression of basophil numbers and function.
These aims will be investigated in a double-blind, randomized, placebo-controlled clinical trial, using standard protocols, including double-blind, placebo-controlled oral food challenges, to evaluate clinical outcomes including long- term efficacy.

Public Health Relevance

The goal of this study will be to validate the clinical efficacy of Chinese herbal medicine in food allergies and to elucidate the mechanisms of action of this herbal formula. This potential therapy has significant advantages over other treatments currently under investigation because it is administered orally, has a high safety profile, and may provide long-term protection from anaphylaxis.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Mentored Patient-Oriented Research Career Development Award (K23)
Project #
5K23AI083883-05
Application #
8468633
Study Section
Allergy & Clinical Immunology-1 (AITC)
Program Officer
Prograis, Lawrence J
Project Start
2009-07-10
Project End
2014-05-31
Budget Start
2013-06-01
Budget End
2014-05-31
Support Year
5
Fiscal Year
2013
Total Cost
$129,465
Indirect Cost
$9,590
Name
Icahn School of Medicine at Mount Sinai
Department
Pediatrics
Type
Schools of Medicine
DUNS #
078861598
City
New York
State
NY
Country
United States
Zip Code
10029
Noone, Sally; Ross, Jaime; Sampson, Hugh A et al. (2015) Epinephrine use in positive oral food challenges performed as a screening test for food allergy therapy trials. J Allergy Clin Immunol Pract 3:424-8
Song, Ying; Wang, Julie; Leung, Nicole et al. (2015) Correlations between basophil activation, allergen-specific IgE with outcome and severity of oral food challenges. Ann Allergy Asthma Immunol 114:319-26
Wang, Julie; Jones, Stacie M; Pongracic, Jacqueline A et al. (2015) Safety, clinical, and immunologic efficacy of a Chinese herbal medicine (Food Allergy Herbal Formula-2) for food allergy. J Allergy Clin Immunol 136:962-970.e1
Agarwal, Shradha; Wang, Julie (2014) Prevalence and characteristics of food allergy in urban minority adults. Ann Allergy Asthma Immunol 112:476-8
Taylor-Black, Sarah A; Mehta, Harshna; Weiderpass, Elisabete et al. (2014) Prevalence of food allergy in New York City school children. Ann Allergy Asthma Immunol 112:554-556.e1
Mehta, Harshna; Ramesh, Manish; Feuille, Elizabeth et al. (2014) Growth comparison in children with and without food allergies in 2 different demographic populations. J Pediatr 165:842-8
Wang, Julie; Fiocchi, Alessandro (2014) Unmet needs in food protein-induced enterocolitis syndrome. Curr Opin Allergy Clin Immunol 14:206-7
Wang, Julie; Young, Michael C; Nowak-Węgrzyn, Anna (2014) International survey of knowledge of food-induced anaphylaxis. Pediatr Allergy Immunol 25:644-50
Yang, Nan; Wang, Julie; Liu, Changda et al. (2014) Berberine and limonin suppress IgE production by human B cells and peripheral blood mononuclear cells from food-allergic patients. Ann Allergy Asthma Immunol 113:556-564.e4
Fiocchi, Alessandro; Wang, Julie (2013) Diet: the key to allergy prevention? Curr Opin Allergy Clin Immunol 13:273-4

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