Mucosal Immunotherapy for Peanut Allergy - Full Text View

Sponsors and Collaborators:	Duke University University of Arkansas
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00597675

Purpose

The purpose of this study is to determine if mucosal peanut immunotherapy will make subjects who have peanut allergy less allergic and induce changes in their immune system.

Condition	Intervention
Food Hypersensitivity	Other: Peanut flour Dietary Supplement: Oat

MedlinePlus related topics: Allergy Food Allergy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Mucosal Immunotherapy for Peanut Allergy

Further study details as provided by Duke University:

Primary Outcome Measures:

An outcome measure will be determined by a comparison of the result of the double blind placebo controlled food challenges (DBPCFC)at the starting point and at the end of the study for each of the subjects. [ Time Frame: Three years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Other outcome measures will be the changes seen in the pre and post peanut skin tests and the pre and post IgE levels to peanut [ Time Frame: Three years ] [ Designated as safety issue: No ]

Estimated Enrollment:	45
Study Start Date:	March 2007
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
MIT: Active Comparator This subject receives mucosal immunotherapy from the beginning and throughout all of the study	Other: Peanut flour Defatted peanut flour
PMIT: Placebo Comparator The subjects in the placebo group receive a placebo mucosal immunotherapy until the first oral food challenge and then cross over to the active mucosal immunotherapy by starting at the beginning	Other: Peanut flour Defatted peanut flour Dietary Supplement: Oat Oat flour

Detailed Description:

Peanut allergy is known to cause severe anaphylactic reactions. Compared with other food allergies it tends to be more persistent and also its prevalence seems to be rising. Currently there is no proven treatment other than strict avoidance. We are attempting to decrease the risk of anaphylaxis on accidental ingestion by desensitizing subjects to peanut using peanut mucosal immunotherapy (MIT). We are also studying the effect of peanut MIT on the peanut specific immune response to determine if tolerance to peanut protein will develop. Children ages one to six with peanut allergy will be randomized to peanut MIT or placebo. Subjects will undergo a modified rush immunotherapy on the first day and then increase the doses at least every two weeks up to a maintenance dose of 4 grams (equivalent to about 13 peanuts). Doses will be taken daily at home except for dose increases which will be done on the DCRU. Outcome variables of interest include response to double-blind placebo controlled food challenge, skin prick testing, peanut specific IgE, and adverse events. These results will be compared between the start and end of peanut MIT using appropriate statistical analysis.

Eligibility

Ages Eligible for Study:	1 Year to 7 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject between 1 and 6 years of age
Diagnosed peanut allergy by RAST greater than or equal to 15 within past 6 months and have eaten peanut in diet resulting in a clinical reaction prior to diagnosis
Diagnosed peanut allergy by RAST greater than or equal to 7 within past 6 months and have had a clinical reaction to peanut ingestion within the past 6 months

Exclusion Criteria:

Subjects with a history of severe, anaphylaxis to peanut
Medical history that would prevent a DBPCFC/OFC to peanut

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00597675

Locations

United States, Arkansas
University of Arkansas Medical Center
Little Rock, Arkansas, United States, 72202

Sponsors and Collaborators

Duke University

University of Arkansas

Investigators

Principal Investigator:

Arvil W Burks, MD

Duke University

More Information

Responsible Party:	Duke University Medical Center ( A. Wesley Burks, MD )
Study ID Numbers:	00000163
Study First Received:	January 4, 2008
Last Updated:	August 25, 2008
ClinicalTrials.gov Identifier:	NCT00597675
Health Authority:	United States: Institutional Review Board

Keywords provided by Duke University:

Peanut allergy

Study placed in the following topic categories:

Food Hypersensitivity
Hypersensitivity
Peanut Hypersensitivity
Hypersensitivity, Immediate

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009