Peanut AllergyNCT02194530
Reduction of Peanut Reactivity and Immune Modulation With Anti-IgE Therapy
An observational study of Peanut Allergy, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Peanut Allergy
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2015to 19 Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: New York Metropolitan area residents
Who may be able to join
- 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)
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- 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)
Who cannot join
- 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).
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Genetic Medicine, Weill Cornell Medicine
New York, New York, 10021
About this study
Official title: Pilot Study to Collect Blood From Research Subjects Allergic and Non-allergic to Peanut to Study Immune Modulation With Anti-IgE Therapy in Mice
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.
Read the 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.
- Conditions
- Peanut Allergy
- Keywords
- Peanut allergic individuals, Allergic/atopic individuals (not allergic to peanut), Non-allergic individuals
- Medical subject headings
- Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2014 (estimated)
- Study start30 Mar 2015
- Primary completion19 Jul 2016
- Study completion19 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peanut AllergyStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronald G Crystal, MD, Principal investigator, Weill Cornell Medical College, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02194530
- Sponsor's protocol ID
- 1405015102
- Status last verified
- Dec 2023
- First submitted
- 16 Jul 2014
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Collect Blood From Research Subjects Allergic and Non-allergic to Peanut to Study Immune Modulation With Anti-IgE Therapy in Mice
- ClinicalTrials.gov ID
- NCT02194530
- Acronym / sponsor ID
- 1405015102
- Conditions
- Peanut Allergy
- Keywords
- Peanut allergic individuals, Allergic/atopic individuals (not allergic to peanut), Non-allergic individuals
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 30 Mar 2015 (actual)
- Primary completion
- 19 Jul 2016 (actual)
- Study completion
- 19 Jul 2016 (actual)
- First posted
- 18 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- New York Metropolitan area residents
Key inclusion criteria (24 listed)
- 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:
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood test to determine peanut allergy and peanut specific IgE and IgG
Time frame: 1 year
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald G Crystal, MD principal investigator
Weill Cornell Medical College, NY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peanut Allergy, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood test to determine peanut allergy and peanut specific IgE and IgG (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.