Development of an Algorithm to Better Predict Clinical Responsiveness to Peanut

NCT00243555 | Unknown

• 2 other identifiers: 2002H05183FP-2005-25
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Peanut Hypersensitivity

Keywords

peanut hypersensitivity; chemokines; cytokines; RNA,messenger; monocytes

Interventions

allergy skin testing PROCEDURE

venepuncture PROCEDURE

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• Food Allergy Initiative: collaborator
• AllerGen NCE Inc.: collaborator

Study Sites (1)

Hamilton Health Sciences Corporation, McMaster Site

Hamilton, Ontario, L8N 3Z5, Canada

RECRUITING

Related Publications (7)

• 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. doi: 10.1016/S0140-6736(05)17704-6.

  PMID: 15639296 BACKGROUND

• 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. doi: 10.1172/JCI16142.

  PMID: 12671056 BACKGROUND

• Umetsu DT. Revising the immunological theories of asthma and allergy. Lancet. 2005 Jan 8-14;365(9454):98-100. doi: 10.1016/S0140-6736(05)17714-9. No abstract available.

  PMID: 15639274 BACKGROUND

• 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. doi: 10.1016/j.jaci.2003.09.026.

  PMID: 14657887 BACKGROUND

• Sampson HA. Update on food allergy. J Allergy Clin Immunol. 2004 May;113(5):805-19; quiz 820. doi: 10.1016/j.jaci.2004.03.014.

  PMID: 15131561 BACKGROUND

• Roberts G, Lack G. Diagnosing peanut allergy with skin prick and specific IgE testing. J Allergy Clin Immunol. 2005 Jun;115(6):1291-6. doi: 10.1016/j.jaci.2005.02.038.

  PMID: 15940149 BACKGROUND

• van Odijk J, Ahlstedt S, Bengtsson U, Borres MP, Hulthen 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. doi: 10.1111/j.1398-9995.2005.00666.x.

  PMID: 15813803 BACKGROUND

MeSH Terms

Conditions

Peanut Hypersensitivity

Interventions

Skin Tests; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques; Specimen Handling; Punctures; Surgical Procedures, Operative

Study Officials

• Susan Waserman, MSc, MD, FRCPC

  Hamilton Health Sciences Corporation, McMaster Site

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Marin, MD

CONTACT

905-521-2100

Study Design

• Study Type: observational
• Observational Model: DEFINED POPULATION
• Time Perspective: OTHER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 20, 2005
• First Posted: October 24, 2005
• Study Start: September 1, 2002
• Last Updated: February 1, 2007

Record last verified: 2006-09

Locations

CA (1)