Double Blind Peanut Sublingual Immunotherapy
Summary
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.
Description
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.
Study Design
Allocation: Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Conditions
Food Hypersensitivity
Intervention
Peanut protein, Glycerol saline drops, Blood draw and skin tests
Location
Duke University Medical Center
Durham
North Carolina
United States
27710
Status
Active, not recruiting
Source
Duke University
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00597727
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Instillation, Drug
The administration of therapeutic agents drop by drop, as eye drops, ear drops, or nose drops. It is also administered into a body space or cavity through a catheter. It differs from irrigation in that the irrigate is removed within minutes, but the instillate is left in place.
Glycerol Kinase
An enzyme that catalyzes the formation of glycerol 3-phosphate from ATP and glycerol. Dihydroxyacetone and L-glyceraldehyde can also act as acceptors; UTP and, in the case of the yeast enzyme, ITP and GTP can act as donors. It provides a way for glycerol derived from fats or glycerides to enter the glycolytic pathway. EC 2.7.1.30.
Phlebotomy
The techniques used to draw blood from a vein for diagnostic purposes or for treatment of certain blood disorders such as erythrocytosis, hemochromatosis, polycythemia vera, and porphyria cutanea tarda.
Leeching
The application of LEECHES to the body to draw blood for therapeutic purposes. Such medicinal leeching, an ancient medical practice, is still being used in microsurgery and the treatment of venous congestion or occlusion.
Haloarcula
A genus of HALOBACTERIACEAE distinguished from other genera in the family by the presence of specific derivatives of TGD-2 polar lipids. Haloarcula are found in neutral saline environments such as salt lakes, marine salterns, and saline soils.
Clinical Trials
Development of an Algorithm to Better Predict Clinical Responsiveness to Peanut
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...
Mucosal Immunotherapy for Peanut Allergy in Young Children
Peanut allergy is known to cause severe anaphylactic reactions.The goal of this proposal is to produce a new treatment that would benefit young subjects who have recently been diagnosed wi...
This is a study in which increasing amounts of peanut flour are given to the children who are peanut allergic to desensitize them to peanut. The hypothesis is that the peanut allergic pati...
Peanut Sublingual Immunotherapy
The purpose of this study is to evaluate the safety and immune response to daily sublingual (under the tongue) immunotherapy (SLIT) with peanut extract in adults and children with peanut a...
Peanut Allergy Vaccine Study in Healthy and Peanut-allergic Adults
The purpose of this study is to evaluate the safety and side effects of a study product that contains recombinant modified peanut proteins (EMP-123) in healthy and peanut-allergic particip...
PubMed Articles
Effects of Peanut-Skin Procyanidin A1 on Degranulation of RBL-2H3 Cells.
Peanut skin contains large amounts of polyphenols having antiallergic effects. We found that a peanut-skin extract (PSE) inhibits the degranulation induced by antigen stimulation of rat basophilic leu...
The local vasoconstriction of infant's skin following instillation of mydriatic eye drops.
BACKGROUND: Systemic absorption of eye drops is known to occur via the nasal mucosa, cornea, and conjunctiva. Diffusion of eye drops through the skin is previously unrecognized. Here, two cases are pr...
Peanut ( Arachis hypogaea , Leguminosae) allergy is a major cause of food-induced anaphylaxis. The potential use of activated charcoal (AC) to adsorb and reduce the bioavailability of peanut protein a...
Maximum flight velocity of blood drops in analysing blood traces.
When analysing blood spatters, traces often occur which regarding the collision angle, cannot be allocated to any supposed centre of origin. Drops following highly curved (ballistic) trajectories usua...
Background The rise in peanut allergy is a source of considerable burden in the community. A growing number of preschoolchildren have been identified as peanut sensitized in the course of investigatio...