Mucosal Immunotherapy for Peanut Allergy (MIT)

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:

NCT00597675

First received: January 4, 2008

Last updated: September 28, 2012

Last verified: September 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 4, 2008

Last Updated Date

September 28, 2012

Start Date ^ICMJE

March 2007

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00597675 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

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

Mucosal Immunotherapy for Peanut Allergy

Official Title ^ICMJE

Mucosal Immunotherapy for Peanut Allergy

Brief Summary

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.

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 research unit. 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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Food Hypersensitivity

Intervention ^ICMJE

Biological: Peanut flour
Defatted peanut flour to be administered
Biological: Oat
Oat flour

Study Arm (s)

Placebo Comparator: Oat flour
This subject receives oat flour from the beginning as the placebo until the unblinding food challenge.

Intervention: Biological: Oat
Active Comparator: Peanut flour
The subjects who receive peanut flour as mucosal immunotherapy at the start and throughout the study

Intervention: Biological: 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

December 2013

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

1 Year to 7 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

NCT00597675

Other Study ID Numbers ^ICMJE

Pro00000163

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:

Arvil W 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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