Status:
COMPLETED
Reduction of Peanut Reactivity and Immune Modulation With Anti-IgE Therapy
Lead Sponsor:
Weill Medical College of Cornell University
Conditions:
Peanut Allergy
Eligibility:
All Genders
18-65 years
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 ato...
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 a...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Groups 1-3:
- Group 1: Peanut allergic individuals (n=20)
- 18-65 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)
- 18-65 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).
- Gastrointestinal-related symptom (i.e., vomiting and diarrhea)
- Group 3: Non-allergic individuals (healthy controls; n=20)
- 18-65 years of age.
- Negative ImmunoCAP test (Optional)
- Documented absence or low total IgE levels, or negativity for an antigen/allergen specific elevated IgE (ie common indoor/outdoor allergens).
- Has not experienced at least one of the following symptoms within 60 minutes of exposure to a particular substance:
- 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)
- Exclusion Criteria for Groups 1-3:
- 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
Exclusion
Key Trial Info
Start Date :
March 30 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 19 2016
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT02194530
Start Date
March 30 2015
End Date
July 19 2016
Last Update
December 6 2023
Active Locations (1)
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1
Department of Genetic Medicine, Weill Cornell Medicine
New York, New York, United States, 10021