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 |
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.
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.
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