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Oral Immunotherapy for Peanut Allergy (PMIT) (PMIT)

This study has been completed.
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 22, 2017
Last verified: March 2017
  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 Phase
Food Hypersensitivity
Biological: Peanut OIT
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Treatment
Official Title: Oral Immunotherapy for Peanut Allergy (2nd Generation PMIT Collaboration With Arkansas Children's)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The Amount of Peanut Protein Ingested Before An Allergic Reaction is Observed During the Double-blind, Placebo Controlled Food Challenge (DBPCFC) After Completing Treatment With Peanut OIT. [ Time Frame: 36-60 months ]
    After completing the peanut OIT protocol (defined as treatment with peanut OIT for at least 36-months AND a peanut-specific IgE >2 and <15 AND skin prick test is <5 mm OR a maximum of 60 months of treatment), the reaction threshold for subjects is assessed by a DBPCFC. This involves eating small increasing doses of peanut protein in a blinded fashion up to a cumulative total of 5000 mg. An identical food challenge is also performed with oat flour as a placebo. The cumulative amount of peanut protein ingested prior to the dose that causes a reaction requiring treatment is reported as the reaction threshold.


Secondary Outcome Measures:
  • The Amount of Peanut Protein Ingested Before An Allergic Reaction is Observed During the Double-blind, Placebo Controlled Food Challenge (DBPCFC) After Completing 12 Months of Blinded Peanut OIT or Placebo Treatment. [ Time Frame: 12 months ]
    After 12 months of blinded Peanut OIT treatment, the reaction threshold for subjects is assessed by a DBPCFC. This involves eating small increasing doses of peanut protein in a blinded fashion up to a cumulative total of 4710 mg. An identical food challenge is also performed with oat flour as a placebo. The cumulative amount of peanut protein ingested prior to the dose that causes a reaction requiring treatment is reported as the reaction threshold.

  • The Change From Baseline Through the End of Peanut OIT Treatment in Wheal Size Diameter Following Peanut Skin Prick Testing [ Time Frame: Baseline to end of open label phase treatment (36-60 months) ]
    Skin prick testing is performed by scratching the skin with a small amount of peanut and observing for redness and a raised bump called a wheal. The diameter of the wheal is measured with a ruler in mm and recorded as a measure of peanut-specific IgE and mast cell reactivity in an allergic subject. A decrease in wheal size after treatment would represent suppression of the allergic response.

  • The Change From Baseline Through the End of Peanut OIT Treatment in Peanut-specific IgE in the Blood [ Time Frame: Baseline to end of open label phase treatment (36-60 months) ]
    Peanut specific IgE on the surface of mast cells and basophils releases histamine when exposed to peanut causing symptoms of allergy. Free-floating peanut-specific IgE is measured from serum in the blood by an immunoCAP machine and reported in kU/L. A lower level of peanut-specific IgE could suggest a decrease in the probability of reaction for a subject who is exposed to peanut.

  • The Change From Baseline Through the End of Peanut OIT Treatment in Peanut-specific IgG4 in the Blood. [ Time Frame: Baseline to end of open label phase treatment (36-60 months) ]
    Peanut specific IgG4 is thought to have a protective effect for a subject when exposed to peanut possibly by interfering with IgE. Peanut-specific IgG4 is measured from serum in the blood by an immunoCAP machine and reported in mg/dL. A higher level of peanut-specific IgG4 could suggest a decrease in the probability of reaction for a subject who is exposed to peanut.


Enrollment: 10
Study Start Date: March 2007
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Oat flour ingested daily as a placebo
Biological: Placebo
Oat flour matched by weight and consistency that is ingested daily as a placebo
Active Comparator: Peanut OIT
Peanut flour ingested daily as oral mucosal immunotherapy
Biological: Peanut OIT
Defatted peanut flour ingested daily as oral mucosal immunotherapy

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 oral mucosal 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 1 to 18 with peanut allergy will be randomized to peanut OIT 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. Subjects will undergo a double-blind, placebo-controlled food challenge (DBPCFC) after 12 months and then be unblinded. Placebo subjects will cross over to open-label peanut OIT and undergo an identical buildup schedule up to 12 months. All subjects will then complete at least 36 months of peanut OIT therapy after which once skin prick (<5 mm) and IgE (<15 kU/L) criteria are met, they will then complete the end of study DBPCFC. Dosing will continue up to a maximum of 60 months after which even if criteria are not met, the subject will undergo the end of study DBPCFC. Outcome variables of interest include response to DBPCFC, 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.
  Eligibility

Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject between 1 and 18 years of age
  • EITHER history of significant clinical symptoms occurring within 60 minutes after ingesting peanuts greater than 6 months ago AND peanut specific IgE >15 kU/L
  • OR history of significant clinical symptoms occurring within 60 minutes after ingesting peanuts within the past 6 months AND peanut specific IgE > 7 kU/L
  • A family that will be able to be compliant with all study visits
  • All females of child bearing age must be using appropriate birth control

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
  • Unable to cooperate with challenge procedures or unable to be reached by telephone for follow-up
  • Diagnosed oat allergy
  • Pregnancy or lactation
  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
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
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

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
Results First Received: January 25, 2017
Last Updated: March 22, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Wesley Burks, MD, University of North Carolina, Chapel Hill:
Peanut allergy

Additional relevant MeSH terms:
Hypersensitivity
Peanut Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on May 25, 2017