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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: September 28, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention
Food Hypersensitivity
 Drug: Peanut flour

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Oral Peanut Immunotherapy for Peanut Allergic Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • IgE to peanut will decrease below a level of 2 [ Time Frame: End of the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: March 2003
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Peanut flour
Subjects, who are peanut allergic, are given peanut flour for desensitization with the hypothesis that they will develop tolerance to peanut.
 Drug: Peanut flour
Defatted Peanut Flour

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   1 Year to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00598039

Locations
United States, Arkansas
University of Arkansas
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
University of North Carolina, Chapel Hill
University of Arkansas
Investigators
Principal Investigator: Wesley Burks, MD University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: Wesley Burks, MD, Chairman, Department of Pediatrics, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00598039     History of Changes
Other Study ID Numbers: 5189
Study First Received: January 6, 2008
Last Updated: September 28, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University of North Carolina, Chapel Hill:
Peanut Allergy

Additional relevant MeSH terms:
Food Hypersensitivity
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013