Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||2 Years - 40 Years|
Inclusion criteria:Patients between 2 and 40 years of age who satisfy all the following criteria will be included:
- - A history suggestive of immediate allergy to peanut/tree nut .
- - The presence of at least one of the following confirmatory tests: - Positive SPT to peanut/tree nut or its proteins (weal diameter 3 mm larger than that of the normal saline control).
- - Detection of serum specific IgE (>0.35 kU/L) to peanut/tree nut or any of its proteins, measured by fluorescence enzyme immunoassay (Phadia, CAP System, Uppsala, Sweden).
- - Positive oral challenge test to peanut/tree nut.
- - Informed consent form signed by the parents or legal guardian.
- - Patients who are unstable from a respiratory point of view .
- - Patients who present with intercurrent disease at the time of starting desensitization.
- - Non-IgE-mediated or non-immunological adverse reactions to nuts.
- - Malignant or immunopathological diseases and/or severe primary or secondary immune deficiencies.
- - Patients receiving immunosuppressor therapy.
- - Patients receiving β-blockers (including topical formulations).
- - Associated diseases contraindicating the use of epinephrine: cardiovascular disease or severe hypertension.
- - Patients diagnosed with eosinophilic gastrointestinal disorder .
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|McGill University Health Centre/Research Institute of the McGill University Health Centre|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Peanut Allergy, Tree Nut Allergy|
The investigators are proposing to initiate a study assessing a common desensitization protocol for peanut/tree nut allergy. This study would enable the investigators to better determine the potential benefit of desensitization in individuals with peanut/tree nut allergy. More specifically, the investigators will address the following research objectives: Objectives A. To develop a protocols for peanut/tree nut desensitization with high (300mg) and low (30mg maintenance dose). B. To determine the rate of desensitization to peanut/tree nut. C. To characterize predictors of successful desensitization. D. To characterize molecular mechanisms involved in the process of desensitization. These objectives will be evaluated through a randomized controlled trial
No Intervention: Control
Following randomization, this arm will receive no intervention. After twelve months, participants in this group will undergo a singe-blind, placebo-controlled oral food challenge
Active Comparator: Low-dose
Following randomization, participants in this group will receive escalating doses of the appropriate allergen, up to a dose of 30 mg. Once they attain that dose, they will maintain it for six months. At the end of this maintenance period, they will undergo a singe-blind, placebo-controlled oral food challenge
Active Comparator: High-dose
Following randomization, participants in this group will receive escalating doses of the appropriate allergen, up to a dose of 300 mg. Once they attain that dose, they will maintain it for six months. At the end of this maintenance period, they will undergo a singe-blind, placebo-controlled oral food challenge
Other: - Oral immunotherapy
Starting from a very low level and over a period of several months, participants receive escalating doses of the food to which they are allergic
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.