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| Sponsored by: |
Duke University |
|---|---|
| Information provided by: | Duke University |
| ClinicalTrials.gov Identifier: | NCT00597727 |
Purpose
The specific aim of this study is to desensitize peanut-allergic subjects with peanut allergen-specific, sublingual immunotherapy (SLIT) by placing drops of peanut protein under the tongue which will be absorbed. The hypothesis is that peanut SLIT will desensitize patients with peanut allergic reactions by changing the subject's immune system to adapt to peanuts.
| Condition | Intervention |
|---|---|
|
Food Hypersensitivity |
Other: Peanut protein Other: Glycerol saline drops Other: Blood draw and skin tests |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Uncontrolled, Crossover Assignment, Safety/Efficacy Study |
| Official Title: | A Double-Blinded, Placebo-Controlled Study of Peanut Sublingual Immunotherapy in Children |
| Estimated Enrollment: | 80 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
SLB01: Active Comparator
Subjects who receive the protein at the beginning of the study.
|
Other: Peanut protein
Peanut protein drops which will be placed under the tongue
|
|
SLB02: Placebo Comparator
Subjects who receive placebo at the beginning of the study.
|
Other: Glycerol saline drops
Glycerol saline drops which will be placed under the tongue
|
|
SL
Control subjects
|
Other: Blood draw and skin tests
Blood draws to compare the immunological system of peanut allergic children to age matched children who are actively participating in the study. Titrated skin prick tests to peanut will also be compared between the 3 groups. |
In spite of increased recognition and understanding of food allergies, food-induced anaphylaxis is the single most common cause of anaphylaxis seen in hospital emergency departments, accounting for about one third of anaphylaxis cases seen. It is estimated that about 30,000 food-induced anaphylactic events are seen in U.S. emergency departments each year and that about 200 fatal cases occur in the U.S. each year. Either peanuts or tree nuts cause more than 80% of these reactions.
The goal of this study is to develop peanut sublingual immunotherapy (IT) for patients with peanut allergic reactions. This study is designed to utilize the extensive knowledge of the allergens involved in peanut hypersensitivity to devise an immunotherapeutic approach that would lower the risk of anaphylactic reactions (systemic IgE-mediated allergic reaction) and would down regulate peanut-specific T cells in peanut-allergic patients.
Eligibility| Ages Eligible for Study: | 1 Year to 11 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| Principal Investigator: | Wesley Burks, MD | Duke University |
| Principal Investigator: | Wesley Burks, MD | Duke University |
More Information
| Responsible Party: | Duke University Medical Center ( A. Wesley Burks, MD ) |
| Study ID Numbers: | 00001553 |
| Study First Received: | January 7, 2008 |
| Last Updated: | June 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00597727 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Peanut Allergy |
|
Food Hypersensitivity Hypersensitivity Glycerol Peanut Hypersensitivity Hypersensitivity, Immediate |
|
Hypersensitivity Food Hypersensitivity Glycerol Immune System Diseases Physiological Effects of Drugs |
Hypersensitivity, Immediate Protective Agents Cryoprotective Agents Pharmacologic Actions |