Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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: March 21, 2014
Last verified: March 2014
  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
Biological: Peanut flour
Biological: Oat

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Mucosal Immunotherapy for Peanut Allergy

Resource links provided by NLM:


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

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 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Oat flour
This subject receives oat flour from the beginning as the placebo until the unblinding food challenge.
Biological: Oat
Oat flour
Active Comparator: Peanut flour
The subjects who receive peanut flour as mucosal immunotherapy at the start and throughout the study
Biological: Peanut flour
Defatted peanut flour to be administered

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.

  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 immunoglobin E to peanut (IgE to peanut) 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 immunoglobin E to peanut (IgE to peanut) 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 double blind placebo controlled oral food challenge (DBPCFC/OFC) to peanut
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University of North Carolina, Chapel Hill
University of Arkansas
Investigators
Principal Investigator: Arvil W 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: NCT00597675     History of Changes
Other Study ID Numbers: Pro00000163
Study First Received: January 4, 2008
Last Updated: March 21, 2014
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
Peanut Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases

ClinicalTrials.gov processed this record on November 24, 2014