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

January 4, 2008
March 21, 2014
March 2007
December 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00597675 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Mucosal Immunotherapy for Peanut Allergy
Mucosal Immunotherapy for Peanut Allergy

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Food Hypersensitivity
  • Biological: Peanut flour
    Defatted peanut flour to be administered
  • Biological: Oat
    Oat flour
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
45
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
1 Year to 7 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00597675
Pro00000163
Yes
Wesley Burks, MD, University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
University of Arkansas
Principal Investigator: Arvil W Burks, MD University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
March 2014

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