Canadian Peanut Thresholds Study

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2013 by McMaster University
Sponsor:
Collaborator:
AllerGen NCE Inc.
Information provided by (Responsible Party):
McMaster University
ClinicalTrials.gov Identifier:
NCT01812798
First received: March 14, 2013
Last updated: NA
Last verified: March 2013
History: No changes posted
  Purpose

An important gap in the management of peanut allergy is that we do not know the threshold dose, below which most peanut allergic individuals will not react. There is likely a spectrum of reactivity to peanut where some individuals react to trace doses, whereas others are able to tolerate larger doses. The purpose of this study is to determine the minimum threshold dose needed to cause a mild objective reaction when peanuts are consumed by peanut-allergic individuals in a carefully controlled clinical setting. 30 peanut-allergic participants aged 7-65 years will undergo a two-day, double blind placebo controlled food challenge. Participants will be gradually fed increasing amounts of peanut, or placebo, until objective allergic symptoms are observed. Statistical modelling of individual threshold doses will be used to determine a population threshold dose, or a level of peanut to which 90% of the peanut-allergic population will not react. Knowledge of threshold doses at an individual and population level is valuable in that it provides critical information for the management of peanut allergy by individuals, their caregivers and health professionals, as well as knowledge of allergen risks to public health agencies and the food industry.


Condition Intervention
Peanut Allergy
Other: Double Blind Placebo Controlled Food Challenge

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Disease Management: Canadian Peanut Thresholds Study

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Peanut threshold dose [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: May 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Peanut

Double Blind Placebo Controlled Food Challenge 5 gram peanut challenge

17 doses of peanut will be administered. Dose will be increased every 20-30 minutes. All doses listed are in g of peanut flour.

0.1 0.25 0.5 0.75

1 2.5 5 10 25 50 100 250 500 750 1000 2500 5000

Other: Double Blind Placebo Controlled Food Challenge

All participants will undergo Double Blind Placebo Controlled Food Challenge. Participants will be randomized to receive either Peanut on Day 1, Placebo on Day 2, or vice versa.

For 'Peanut' arm, participants will be fed increasing doses of peanut until mild objective allergic reaction is observed.

Doses will be increased every 20-30 minutes. All doses are listed in g peanut flour

0.1 0.25 0.5 0.75

1 2.5 5 10 25 50 100 250 500 750 1000 2500 5000

For "Placebo" arm, participants will be fed increasing amounts of food matrix without peanut flour.

Placebo Comparator: Placebo
Double Blind Placebo Controlled Food Challenge (No peanut - placebo only)
Other: Double Blind Placebo Controlled Food Challenge

All participants will undergo Double Blind Placebo Controlled Food Challenge. Participants will be randomized to receive either Peanut on Day 1, Placebo on Day 2, or vice versa.

For 'Peanut' arm, participants will be fed increasing doses of peanut until mild objective allergic reaction is observed.

Doses will be increased every 20-30 minutes. All doses are listed in g peanut flour

0.1 0.25 0.5 0.75

1 2.5 5 10 25 50 100 250 500 750 1000 2500 5000

For "Placebo" arm, participants will be fed increasing amounts of food matrix without peanut flour.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   7 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Children and adults between 7-65 years of age.
  2. Demonstrated history of peanut allergy based on medical history, positive skin prick test, and peanut-specific IgE CAP-FEIA test. Participants will be confirmed to have peanut allergy based on a history of significant clinical symptoms within 60 minutes of the ingestion of peanut, the presence of specific IgE to peanut (a positive skin prick test to peanut, defined as a wheal 3 mm larger than that of the saline control, and a positive in vitro peanut-specific IgE (CAP-FEIA) test value >0.35 IU/mL.
  3. Ability to discontinue all prescribed and over the counter allergy-related medications for suitable withdrawal periods before starting the challenge trial. See Appendix I for specifications.

Exclusion Criteria:

  1. Previous desensitization treatment to peanut
  2. Allergies to any component of the oral challenge matrix
  3. Unstable allergic conditions such as uncontrolled asthma or chronic urticaria
  4. Any clinically significant disease/chronic medical condition which may interfere with study evaluations
  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: NCT01812798

Contacts
Contact: Christina Taggart, MA christina.taggart@gmail.com

Locations
Canada, Ontario
McMaster University Not yet recruiting
Hamilton, Ontario, Canada, L8S 4K1
Contact: Christina Taggart, MA       christina.taggart@gmail.com   
Sponsors and Collaborators
McMaster University
AllerGen NCE Inc.
Investigators
Principal Investigator: Susan Waserman, MD McMaster University
  More Information

No publications provided

Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT01812798     History of Changes
Other Study ID Numbers: 12LP3.7
Study First Received: March 14, 2013
Last Updated: March 14, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
Peanut allergy
Threshold
Modelling
Risk assessment

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

ClinicalTrials.gov processed this record on July 28, 2014