Canadian Peanut Thresholds Study

NCT01812798 | Unknown

• 1 other identifier: 12LP3.7
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peanut Allergy

Keywords

Peanut allergy; Threshold; Modelling; Risk assessment

Outcome Measures

Primary Outcomes (1)

• Peanut threshold dose

  30 minutes

Study Arms (2)

Peanut

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Other: Double Blind Placebo Controlled Food Challenge

Interventions

Double Blind Placebo Controlled Food Challenge OTHER

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.

Peanut; Placebo

Eligibility Criteria

• Age: 7 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Children and adults between 7-65 years of age.
• 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.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• McMaster University: lead
• AllerGen NCE Inc.: collaborator

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4K1, Canada

Location

MeSH Terms

Conditions

Peanut Hypersensitivity

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Susan Waserman, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2013
• First Posted: March 18, 2013
• Study Start: May 1, 2013
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: June 4, 2020

Record last verified: 2020-05

Locations

CA (1)