Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
80

Exclusion Criteria

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).
Acute infection receiving any antibiotics within 30 days prior to screening
Known illicit drug or alcohol abuse
...
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).
Acute infection receiving any antibiotics within 30 days prior to screening
Known illicit drug or alcohol abuse
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
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)
Prior therapy with anti-IgE
Steroid use greater than 10 mg/d prednisone or equivalent 30 days prior to enrollment
Pregnancy

Summary

Conditions
Peanut Allergy
Type
Observational
Design
  • Observational Model: Case-Control
  • Time Perspective: Prospective

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

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...

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.

Exclusion Criteria

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).
Acute infection receiving any antibiotics within 30 days prior to screening
Known illicit drug or alcohol abuse
...
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).
Acute infection receiving any antibiotics within 30 days prior to screening
Known illicit drug or alcohol abuse
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
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)
Prior therapy with anti-IgE
Steroid use greater than 10 mg/d prednisone or equivalent 30 days prior to enrollment
Pregnancy

Tracking Information

NCT #
NCT02194530
Collaborators
Not Provided
Investigators
  • Principal Investigator: Ronald G Crystal, MD Weill Cornell Medical College, NY
  • Ronald G Crystal, MD Weill Cornell Medical College, NY
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