Single Center Food Allergy Oral Immunotherapy Study



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:4 - 55
Updated:4/21/2016
Start Date:November 2011
End Date:April 2014

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Single Center, Phase I Food Allergy Oral Immunotherapy Study

The Primary Objective of the study is to develop a customized regimen for oral immunotherapy
that reflects what the subject is allergic in a clinically significant way (i.e., the
offending food allergen is defined as a food allergen with a positive skin test or positive
specific IgE and a positive DBPCFC). Therefore, the investigators prefer that both single
and multiple food allergy subjects are included in the study.


Inclusion Criteria:

- Moderate to severe peanut and/or egg and/or milk and/or tree nut and/or seed allergic
subjects between the ages of 4 to 55 years old.

- Sensitivity to food allergen will be documented by a positive skin prick test result
(see Appendix for details) or allergen specific ImmunoCAP IgE level with 7 kU/L as a
lower limit of eligibility.

Exclusion Criteria:

- No absolute contraindications are known. However, the risk of serious systemic
anaphylactic reactions to food allergens suggests a number of preexisting conditions
that should be considered relative contraindications. Among those conditions are
acute infections, autoimmune disease, severe cardiac disease, and treatment with
beta-adrenergic antagonistic drugs (beta-blockers).

- Subjects having a history of severe anaphylaxis to food allergens that will be
desensitized in this study requiring intubation or admission to an ICU, frequent
allergic or non-allergic urticaria, or history consistent with poorly controlled
persistent asthma.
We found this trial at
1
site
291 Campus Dr
Stanford, California 94305
(650) 725-3900
Stanford University School of Medicine Vast in both its physical scale and its impact on...
2100
mi
from 43215
Stanford, CA
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