Reduction of Peanut Reactivity and Immune Modulation With Anti-IgE Therapy

NCT02194530 | Completed

• 1 other identifier: 1405015102
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peanut Allergy

Keywords

Peanut allergic individuals; Allergic/atopic individuals (not allergic to peanut); Non-allergic individuals

Outcome Measures

Primary Outcomes (1)

• Blood test to determine peanut allergy and peanut specific IgE and IgG

  There will be one blood draw 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.

  1 year

Study Arms (3)

Peanut allergic individuals

20 individuals will be recruited for this group. Each blood draw will require 105 ml of whole blood to be collected in ten heparinized 10 mL tubes and one EDTA tube.

Allergic/atopic individuals (not peanut)

Subjects should not be allergic to peanut. 20 individuals will be recruited for this group. Each blood draw will require 105 ml of whole blood to be collected in ten heparinized 10 mL tubes and one EDTA tube.

Non-allergic individuals

20 individuals will be recruited for this group. Each blood draw will require 105 ml of whole blood to be collected in ten heparinized 10 mL tubes and one EDTA tube.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

New York Metropolitan area residents

You may qualify if:

• Group 1: Peanut allergic individuals (n=20)
• years of age
• Positive ImmunoCAP test (Optional)
• Documented elevated total IgE levels, peanut positivity or another antigen/allergen specific elevated IgE (ie common indoor/outdoor allergens)
• Experienced at least one of the following symptoms within 60 minutes of exposure:
• Skin-related symptom (i.e., hives and edema)
• Respiratory-related symptom (i.e., wheezing, throat tightness, repetitive coughing, and dyspnea)
• Gastrointestinal-related symptom (i.e., vomiting and diarrhea)
• Group 2: Allergic/atopic individuals (not allergic to peanut; n=20)
• years of age.
• Positive ImmunoCAP test (Optional)
• Documented elevated total IgE levels or an indoor/outdoor antigen/allergen (other than peanut) specific elevated IgE (ie common indoor/outdoor allergens).
• Experienced at least one of the following symptoms within 60 minutes of exposure:
• Skin-related symptom (i.e., hives and edema).
• Respiratory-related symptom (i.e., wheezing, throat tightness, repetitive coughing, and dyspnea).

You may not qualify if:

• Prior therapy with anti-IgE
• Steroid use greater than 10 mg/d prednisone or equivalent 30 days prior to enrollment
• Any immunosuppressive drug use within 3 months prior to screening (mycophenolate mofetil, hydroxychloroquine, azathioprine, methotrexate, leflunomide, rituximab, cyclophosphamide, intravenous immunoglobulin, plasmapheresis)
• Ongoing chronic infection (viral, bacterial or fungal) including known HIV, Hepatitis B/C
• Acute infection receiving any antibiotics within 30 days prior to screening
• Probiotics (greater than estimated 109 cfu or organisms per day) within 30 days prior to enrollment (with the exception of fermented beverages, milks or yogurts).
• Malignancy within one year prior to screening (with the exception of non-metastatic squamous or basal cell skin carcinomas and cervical carcinoma if received curative surgical treatment)
• Known illicit drug or alcohol abuse
• Pregnancy

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Department of Genetic Medicine, Weill Cornell Medicine

New York, New York, 10021, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Peanut Hypersensitivity

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Ronald G Crystal, MD

  Weill Cornell Medical College, NY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2014
• First Posted: July 18, 2014
• Study Start: March 30, 2015
• Primary Completion: July 19, 2016
• Study Completion: July 19, 2016
• Last Updated: December 6, 2023

Record last verified: 2023-12

Locations

US (1)