Reduction of Peanut Reactivity and Immune Modulation With Anti-IgE Therapy
Condition: Peanut Allergy
MeSH terms: Peanut Hypersensitivity
Study type: Observational

Summary: 
      This pilot study is will examine the pathways involved in allergic response, primarily in
      food allergy; specifically peanut allergy. We will also study non-allergic donors as well as
      patients with atopic disorders, primarily as control subjects. We believe that this study
      will lead to discovery of significant pathways involved in the allergic pathway that can be
      explored in more detail during follow-up studies in order to address mechanistic questions
      that cannot be answered in a pilot trial. We believe that such a pilot study represents the
      ideal approach to identify effective therapeutic interventions and to simultaneously better
      understand the underlying mechanistic properties involved in the allergy cascade. We think
      that this study forms the basis for a novel avenue of research into the pathogenesis of
      allergic pathways, a disease that is still associated with significant morbidity and
      mortality.
    

Detailed description: 
      The study aims to characterize the pathways involved in the allergic response, primarily in
      food allergy; specifically peanut allergy. We will also study non-allergic donors as well as
      patients with atopic disorders, primarily as control subjects. All eligible study
      participants will have documented elevated total IgE levels, peanut positivity or another
      antigen/allergen specific elevated IgE (ie common indoor/outdoor allergens) prior to being
      enrolled in the study. Our study will focus on allergic as well as non-allergic individuals.
      We plan on collecting samples from a total of 60 patients during one time point (peanut
      allergic individuals, non-atopic/allergic individuals, atopic individuals-other than peanut
      allergy). We believe that such a pilot study represents the ideal approach to identify
      effective therapeutic interventions and to simultaneously better understand the underlying
      mechanistic properties involved in the allergy cascade. We plan to obtain a detailed history
      prior to enrollment as well as objective data (ie SPT as well as Immunocap testing results).
      There will be 3 study groups and studies will be performed on approximately 20 peanut
      allergic patients, 20 non-allergic controls, and 20 allergic/atopic (non-peanut allergic, but
      allergic to indoor/outdoor allergen) individuals. There will be one blood draw required at
      each visit (weeks 0, 4, 8). Each blood draw will require 105 ml of whole blood to be
      collected in ten heparinized 10-mL tubes and one EDTA tube. We plan to assess the levels of
      total IgE and IgG as well as antigen specific IgG and IgE in the peripheral blood of
      patients. We will specifically perform ELISA testing that detects these levels. We will also
      perform in vitro CD4+ T cell proliferation assays. For this purpose, patients' peripheral T
      cells will be isolated with a combination of magnetic beads and flow cytometric sorting.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        New York Metropolitan area residents
      
Biospecimen description: 
      Whole blood
    
Keywords: Peanut allergic individuals; Allergic/atopic individuals (not allergic to peanut); Non-allergic individuals