Canadian Peanut Thresholds Study
Study 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.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
Yes |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 7 Years - 65 Years |
Gender | All |
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT01812798 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
N/A |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
McMaster University |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Susan Waserman, MD |
Principal Investigator Affiliation | McMaster University |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other, Industry |
Overall Status | Active, not recruiting |
Countries | Canada |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Peanut Allergy |
Contact a Trial Team
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