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Double Blind Peanut Sublingual Immunotherapy (PN SLIT)
This study is ongoing, but not recruiting participants.
Study NCT00597727   Information provided by Duke University
First Received: January 7, 2008   Last Updated: June 10, 2009   History of Changes

January 7, 2008
June 10, 2009
January 2008
December 2014   (final data collection date for primary outcome measure)
Subject will successfully pass a double blind placebo controlled food challenge at the end of the study after having been off the sublingual immunotherapy for 2 to 4 weeks. [ Time Frame: End of the study ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00597727 on ClinicalTrials.gov Archive Site
The peanut specific IgE will have decreased from the level at the start of the study. [ Time Frame: End of the study ] [ Designated as safety issue: No ]
Same as current
 
Double Blind Peanut Sublingual Immunotherapy
A Double-Blinded, Placebo-Controlled Study of Peanut Sublingual Immunotherapy in Children

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.

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.

 
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Uncontrolled, Crossover Assignment, Safety/Efficacy Study
Food Hypersensitivity
  • Other: Peanut protein
  • Other: Glycerol saline drops
  • Other: Blood draw and skin tests
  • Active Comparator: Subjects who receive the protein at the beginning of the study.
  • Placebo Comparator: Subjects who receive placebo at the beginning of the study.
  • Other: Control subjects
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
80
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Peanut IgE > 7kU/L (> 2kU/L for children aged 2 years and under) AND
  • History of significant clinical symptoms within 60 minutes after the ingestion of peanuts.

Exclusion Criteria:

  • History of severe life-threatening anaphylaxis to peanut,
  • Medical history that would prevent a DBPCFC to peanut,
  • Unable to cooperate with challenge procedures, or
  • Unable to be reached by telephone for follow-up.
Both
1 Year to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00597727
A. Wesley Burks, MD, Duke University Medical Center
00001553
Duke University
 
Principal Investigator: Wesley Burks, MD Duke University
Principal Investigator: Wesley Burks, MD Duke University
Duke University
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP