Peanut Hypersensitivity Clinical Trial
Official title:
Molecular Analysis of Immuno-Regulatory Genes Expressed by Mononuclear Cells From Peanut Skin Test Positive Individuals With and Without a History of Peanut Ingestion
The purpose of this study is to develop a tool to better predict clinical allergy to peanut, so that those who are skin test positive but non allergic will not have to unnecessarily avoid peanut, and those with true allergy can be diagnosed, possibly without oral ingestion challenge, and treated appropriately
Status | Recruiting |
Enrollment | 60 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 5 Years and older |
Eligibility |
Inclusion Criteria: - 5 years of age and older - Informed consent (Subject has provided an appropriately signed and dated informed consent. An appropriately signed and dated assent must be obtained from the parents or guardian if the subject is a child under 18 years of age.) - Free of any clinically significant disease, such as uncontrolled asthma, which may interfere with study evaluations Group 1: - skin test positive to peanut - documented clinical history of peanut allergy. A documented clinical history may include symptoms such as hives,swelling of the mouth or tongue, throat closing sensation, shortness of breath, wheezing, lightheadedness, anaphylaxis. Group 2: - Positive skin test to peanut - History of being able to tolerate peanut exposure without problems Group 3: - Positive skin test to peanut - No known ingestion of peanut Group 4: - Negative skin test to peanut - Negative skin test to other food and environmental allergens - Able to tolerate peanut exposure without problems Exclusion Criteria: - Women who are pregnant or nursing - use of antihistamines or decongestant therapy four days prior to clinic visit - use of nasal or inhaled corticosteroid in the 1 month period prior to clinic visit - use of non-steroidal anti-inflammatory drugs (NSAIDS) in the week prior to clinic visit - Moderate or severe/ uncontrolled asthma (defined as the use of more than 4 puffs of ventolin per day, not including prophylactic medications prior to exercise) - Symptomatic allergic rhinitis - Patients who had an acute allergic reaction to food, drugs, and bee sting in the 1 month period prior to clinic visit - Use of an epi-pen during the past month - respiratory infection one month prior to clinic visit - immunotherapy |
Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
Canada | Hamilton Health Sciences Corporation, McMaster Site | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
Hamilton Health Sciences Corporation | AllerGen NCE Inc., Food Allergy Initiative |
Canada,
Heaton T, Rowe J, Turner S, Aalberse RC, de Klerk N, Suriyaarachchi D, Serralha M, Holt BJ, Hollams E, Yerkovich S, Holt K, Sly PD, Goldblatt J, Le Souef P, Holt PG. An immunoepidemiological approach to asthma: identification of in-vitro T-cell response patterns associated with different wheezing phenotypes in children. Lancet. 2005 Jan 8-14;365(9454):142-9. — View Citation
Kagan RS, Joseph L, Dufresne C, Gray-Donald K, Turnbull E, Pierre YS, Clarke AE. Prevalence of peanut allergy in primary-school children in Montreal, Canada. J Allergy Clin Immunol. 2003 Dec;112(6):1223-8. — View Citation
Roberts G, Lack G. Diagnosing peanut allergy with skin prick and specific IgE testing. J Allergy Clin Immunol. 2005 Jun;115(6):1291-6. — View Citation
Sampson HA. Update on food allergy. J Allergy Clin Immunol. 2004 May;113(5):805-19; quiz 820. Review. — View Citation
Turcanu V, Maleki SJ, Lack G. Characterization of lymphocyte responses to peanuts in normal children, peanut-allergic children, and allergic children who acquired tolerance to peanuts. J Clin Invest. 2003 Apr;111(7):1065-72. — View Citation
Umetsu DT. Revising the immunological theories of asthma and allergy. Lancet. 2005 Jan 8-14;365(9454):98-100. — View Citation
van Odijk J, Ahlstedt S, Bengtsson U, Borres MP, Hulthén L. Double-blind placebo-controlled challenges for peanut allergy the efficiency of blinding procedures and the allergenic activity of peanut availability in the recipes. Allergy. 2005 May;60(5):602-5. — View Citation
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