Peanut Oral Immunotherapy (Peanut OIT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Arkansas
Information provided by (Responsible Party):
Wesley Burks, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00598039
First received: January 6, 2008
Last updated: March 21, 2014
Last verified: March 2014

January 6, 2008
March 21, 2014
March 2003
July 2014   (final data collection date for primary outcome measure)
Subject will pass a double blind placebo food challenge (DBPCFC) at the end of the study and a second food challenge 1 month later after being off of peanut for 1 month. [ Time Frame: End of study ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00598039 on ClinicalTrials.gov Archive Site
IgE to peanut will decrease below a level of 2 [ Time Frame: End of the study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Peanut Oral Immunotherapy
Oral Peanut Immunotherapy for Peanut Allergic Patients

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 patients would benefit from the desensitization by assuring that they will not have life-threatening allergic reactions to contaminating amounts of peanut in other foods and eventually it would cause them to lose their clinical sensitivity to peanut.

Peanut allergy is one of the most serious of the immediate hypersensitivity reactions to foods in terms of persistence and severity of the reaction and appears to be a growing problem. Due to the persistence of this reaction and the lack of effective treatment, allergen-specific immunotherapy (IT)using the oral route of ingestion is currently being examined as a treatment option. An understanding of the molecular mechanisms of peanut-specific IT is vital to ensure the eventual, successful treatment of peanut-allergic patients.

This study will examine not only the child's response to the oral peanut flour but will also examine the changes in the immunological system which is responsible for the peanut allergy.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Food Hypersensitivity
Drug: Peanut flour
Defatted Peanut Flour
Experimental: Peanut flour
Subjects, who are peanut allergic, are given peanut flour for desensitization with the hypothesis that they will develop tolerance to peanut.
Intervention: Drug: Peanut flour
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
July 2014
July 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects between 1 and 16 years of age
  • Diagnosed peanut allergy by either: 1) a positive prick skin test to peanuts, CAP FEIA of 15 or greater and a history of significant clinical symptoms within one hour after ingestion of peanuts or 2) a positive prick skin test to peanuts, CAP FEIA of ≥ 7 and a history of a clinical reaction to peanut ingestion within the past 6 months.
  • A family that will be able to be compliant with all study visits

Exclusion Criteria:

  • Subjects with a history of severe anaphylaxis to peanut
  • Subjects with a medical history that would prevent a DBPCFC/OFC to peanut
  • Subjects 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
 
NCT00598039
5189
Yes
Wesley Burks, MD, University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
University of Arkansas
Principal Investigator: Wesley Burks, MD University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
March 2014

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