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

Tracking Information

First Received Date ^ICMJE

January 6, 2008

Last Updated Date

September 28, 2012

Start Date ^ICMJE

March 2003

Estimated Primary Completion Date

July 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00598039 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Peanut Oral Immunotherapy

Official Title ^ICMJE

Oral Peanut Immunotherapy for Peanut Allergic Patients

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Food Hypersensitivity

Intervention ^ICMJE

Drug: Peanut flour

Defatted Peanut Flour

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2014

Estimated Primary Completion Date

July 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

1 Year to 16 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00598039

Other Study ID Numbers ^ICMJE

5189

Has Data Monitoring Committee

Yes

Responsible Party

Wesley Burks, MD, University of North Carolina, Chapel Hill

Study Sponsor ^ICMJE

University of North Carolina, Chapel Hill

Collaborators ^ICMJE

University of Arkansas

Investigators ^ICMJE

Principal Investigator:

Wesley Burks, MD

University of North Carolina, Chapel Hill

Information Provided By

University of North Carolina, Chapel Hill

Verification Date

September 2012

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

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