Oral Immunotherapy (OIT) for Peanut Allergy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Wesley Burks, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00815035
First received: December 26, 2008
Last updated: March 21, 2014
Last verified: March 2014

December 26, 2008
March 21, 2014
April 2009
November 2015   (final data collection date for primary outcome measure)
To treat peanut-allergic subjects with peanut OIT and to determine whether this protocol lowers their risk of anaphylactic reactions and causes long-term tolerance. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00815035 on ClinicalTrials.gov Archive Site
To determine the molecular-level effect that peanut OIT has on the peanut-specific cellular and humoral activity/response in peanut-allergic subjects. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Oral Immunotherapy (OIT) for Peanut Allergy
Oral Immunotherapy for Peanut Allergy

Peanut allergy is known to cause severe anaphylactic reactions.The goal of this proposal is to produce a new treatment that would benefit subjects who have peanut allergy by lowering the risk of anaphylactic reactions (desensitization), and changing the peanut-specific immune response in subjects who have peanut allergy (tolerance).

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 oral immunotherapy (OIT). We are also studying the effect of peanut OIT on the peanut specific immune response to determine if tolerance to peanut protein will develop. Children ages one to six years of age with peanut allergy will be randomized to peanut OIT or placebo (active subjects). Thirty subjects will also be recruited as controls. These subjects will not receive any peanut or placebo but only have skin prick testing and lab work in addition to a history and physical exam. Active 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 OIT using appropriate statistical analysis.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Peanut Hypersensitivity
  • Drug: Peanut flour
    Peanut flour will be given in increasing amounts.
  • Drug: Subjects will receive oral oat flour.
    The doses of oat flour will be increases every 2 weeks until a maintenance dose is achieved.
  • Active Comparator: Peanut
    These subjects will be randomized to receive the active peanut protein.
    Intervention: Drug: Peanut flour
  • Placebo Comparator: Oat flour
    These subjects will be randomized to receive oat flour.
    Intervention: Drug: Subjects will receive oral oat flour.
  • No Intervention: Control arm
    Subjects will be enrolled who meet the inclusion/exclusion criteria and followed as matched controls. These subjects will not receive any treatment.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
November 2015
November 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 1- 6 years all of either sex, any race, any ethnicity at the time of the initial visit
  • The presence of IgE specific to peanuts (a positive skin prick test to peanuts (diameter of wheal >3.0 mm) and a positive in vitro IgE [CAP-FEIA] > 7 kUA/L
  • A history of significant clinical symptoms occurring within 60 minutes after ingesting peanuts
  • Provide signed informed consent

Exclusion Criteria:

  • History of severe anaphylaxis to peanut as defined by hypoxia, hypotension, or neurological compromise (Cyanosis or oxygen saturation < 92% at any stage, hypotension, confusion, collapse, loss of consciousness; or incontinence)
  • Currently participating in a study using an investigational new drug
  • Participation in any interventional study for the treatment of food allergy in the past 12 months
  • Subjects with a known wheat food allergy will be excluded because of cross contamination of oat with wheat
  • Poor control or persistent activation of atopic dermatitis
  • Moderate to severe persistent asthma
  • Currently being treated with greater than medium daily doses of inhaled corticosteroids, as defined by the National Heart Lung and Blood Institute (NHLBI) guidelines
  • Inability to discontinue antihistamines for skin testing and oral food challenges (OFCs)
Both
1 Year to 6 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00815035
00008152, 5R01-AI068074-02
Yes
Wesley Burks, MD, University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
Not Provided
Principal Investigator: Wesley Burks, MD University of North Carolina
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