Full Text View
Tabular View
No Study Results Posted
Related Studies
Egg Oral Immunotherapy (Egg OIT)
This study is ongoing, but not recruiting participants.
Study NCT00597558   Information provided by Duke University
First Received: January 6, 2008   Last Updated: August 25, 2008   History of Changes

January 6, 2008
August 25, 2008
February 2003
July 2012   (final data collection date for primary outcome measure)
Subjects on egg OIT will have a negative double-blind, placebo-controlled food challenge (DBPCFC) to egg when the IgE is < 2 kU/l. [ Time Frame: End of the study ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00597558 on ClinicalTrials.gov Archive Site
Subjects on OIT will have a decrease in serum CAP-FEIA to egg over the course of the study. [ Time Frame: End of the study ] [ Designated as safety issue: No ]
Same as current
 
Egg Oral Immunotherapy
Treatment of Egg Allergy in Children Through Oral Desensitization

The purpose of this study is to determine if children with egg allergy can be desensitized to egg protein and if this desensitization can help them outgrow their egg allergy at an earlier time than normal. Our hypothesis is that children with egg allergy can be orally desensitized to egg protein and that this desensitization will help them outgrow their egg allergy at an earlier time than normal.

Egg allergy in children under 5 years of age is extremely common. Egg, along with milk and peanuts, cause 80% of the food allergy reactions in children in the United States. Children have allergic reactions to egg ranging from mild urticaria to systemic anaphylaxis. The current therapy for children with egg allergy is to place the child on an egg-free diet until the allergy is outgrown. Because egg protein is a part of a significant number of processed foods it is difficult to totally avoid all egg proteins. Accidental ingestions leading to reactions to egg can occur with a bite of a cookie (~70 mg of egg protein) or a bite of a cake (~55 mg of egg protein). Children typically do not outgrow their egg allergy for several years. Therefore it would be helpful if a specific form of therapy would make children outgrow their allergic reactions to egg sooner. Egg protein is given to children in this study in small increasing amounts to desensitize them to the egg protein with the goal of helping them to outgrow their allergy.

 
Interventional
Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Food Hypersensitivity
Other: Egg white protein
 
Buchanan AD, Green TD, Jones SM, Scurlock AM, Christie L, Althage KA, Steele PH, Pons L, Helm RM, Lee LA, Burks AW. Egg oral immunotherapy in nonanaphylactic children with egg allergy. J Allergy Clin Immunol. 2007 Jan;119(1):199-205. Epub 2006 Oct 27.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
12
July 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Between 1 to 16 years of age
  • Diagnosed egg allergy by CAP FEIA of 7 kU/l or greater (2 kU/l or greater if 2 years old or less) or have had a positive allergic reaction to egg within 6 months.
  • Having eaten egg in his/her diet prior to diagnosis
  • A family that will be able to be compliant with all study visits

Exclusion Criteria:

  • History of anaphylaxis to egg
  • Medical history that would prevent an OFC or DBPCFC to egg
  • Unable to cooperate with challenge procedures or unable to be reached by telephone for follow-up
Both
1 Year to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00597558
A. Wesley Burks, MD, Duke University Medical Center
5111, 5111
Duke University
University of Arkansas
Principal Investigator: Wesley Burks, MD Duke University
Duke University
August 2008

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