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View Clinical Trial (Medical Research Study)
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Mucosal Immunotherapy for Peanut Allergy in Young Children - NCT00932828-27710 (Clinical Trial 300832)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy300832.aspx
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| City: |
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Durham |
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State:
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NC |
| Zip Code: |
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27710 |
| Conditions: |
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Food Hypersensitivity |
| Purpose: |
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Peanut allergy is known to cause severe anaphylactic reactions.The goal of this proposal is
to produce a new treatment that would benefit young subjects who have recently been
diagnosed with peanut allergy by lowering the risk of anaphylactic reactions
(desensitization), and changing the peanut-specific immune response in subjects who have
peanut allergy (tolerance).
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| Study summary: |
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Peanut allergy is known to cause severe anaphylactic reactions. Compared with other food
allergies, it tends to be more persistent and its prevalence seems to be rising. Currently,
there is no proven treatment other than strict avoidance. We are attempting to decrease the
risk of anaphylaxis on accidental ingestion by desensitizing subjects to peanut using peanut
mucosal immunotherapy (PMIT). We are also studying the effect of PMIT on the peanut-specific
immune response to determine if tolerance to peanut protein will develop. Based on our
preliminary work and recent studies supporting the importance of early oral exposure in
tolerance induction, we propose that early treatment of peanut allergy with PMIT will be
safe and effective. Children ages 9 to 36 months with peanut allergy will be randomized to
receive high or low dose PMIT using peanut flour. Peanut-allergic subjects receiving no
intervention will serve as controls. Subjects will undergo desensitization on the first day
and then increase the doses gradually to a maintenance dose. Doses will be taken daily at
home except for dose increases which will be done on the Duke Clinical Research Unit.
Subjects will undergo a double-blinded, placebo-controlled food challenge (DBPCFC) if
challenge criteria are met. Subjects passing the first challenge will stop PMIT and repeat
the DBPCFC to assess tolerance. Outcome variables of interest include response to
double-blind placebo controlled food challenges, skin prick testing, peanut specific serum
IgE, IgG, and IgG4 and stool IgA, T and B cell responses, quality of life, and adverse
events. These longitudinal results will be compared between high and low dose PMIT groups
and controls using appropriate statistical analysis. |
| Criteria: |
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Inclusion Criteria:
- Age 9-36 months of either sex, any race, any ethnicity at the time of the initial
visit
- EITHER a positive skin prick test to peanuts or in vitro [CAP-FEIA] peanut IgE level
in the blood > 0.35 kU/L PLUS a history of a clinical allergic reaction (defined as
significant clinical symptoms occurring within 60 minutes after ingesting peanuts)
within 6 months of screening
- OR a positive prick skin test to peanuts and in vitro [CAP-FEIA] peanut IgE level > 5
kU/L when there is no history of allergic reaction and no known peanut exposure
- Provision of signed informed consent
- Development of symptoms characteristic of IgE-mediated food allergy (urticaria,
angioedema, respiratory distress/wheeze/cough, vomiting/diarrhea, anaphylaxis) during
initial oral food challenge
Exclusion Criteria:
- History of severe anaphylaxis to peanut as defined by hypoxia, hypotension, or
neurological compromise
- Currently participating in a study using an investigational new drug
- Participation in any interventional study for the treatment of food allergy in the
past 12 months
- Subjects with a known wheat food allergy will be excluded because of cross
contamination of oat with wheat
- Severe atopic dermatitis
- Currently being treated with greater than medium daily doses of inhaled
corticosteroids, as defined by the NHLBI guidelines
- Inability to discontinue antihistamines for skin testing and OFCs |
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| Study is available at: |
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Duke University Medical Center
Durham, NC 27710
United States
Primary Contact:
Pamela H Steele, CPNP
Email: pamela.steele@duke.edu
Phone: 919-668-1333
Secondary Contact:
Pamela H Steele, CPNP
Email: pamela.steele@duke.edu
Phone: 919-668-1333 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 17, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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