Clinical Trials

Peanut and Tree Nut Desensitization

Study Purpose

this study evaluates whether tolerance to peanuts and tree nuts can be induced in patients through a process of oral immunotherapy. Participants will be randomized into groups receiving oral immunotherapy and a control group that will receive no intervention

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
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	2 Years - 40 Years
Gender	All

More Inclusion & Exclusion Criteria

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 .

A convincing clinical history of an IgE mediated reaction to a specific food will be defined as a minimum of 2 mild signs/symptoms or 1 moderate or 1 severe sign/symptom that was likely IgE mediated and occurred within 120 minutes after ingestion or contact (or inhalation in the case of fish and shellfish). Reactions will be considered mild if they involve pruritus, urticaria, flushing, or rhinoconjunctivitis; moderate if they involve angioedema, throat tightness, gastrointestinal complaints, or breathing difficulties (other than wheeze); and severe if they involve wheeze, cyanosis, or circulatory collapse.(54-57)

- 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).

The allergens used will be commercial extracts of peanut/tree nut (Omega Labs, Toronto, Ontario).

- 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.

Oral challenges will be performed with raw peanut/tree nut according to the recommendations of the position paper of the European Academy of Allergology and Clinical Immunology (58).

- Informed consent form signed by the parents or legal guardian.

Exclusion criteria.

- 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 .

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.	NCT03532360
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.	McGill University Health Centre/Research Institute of the McGill University Health Centre
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	Canada
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Peanut Allergy, Tree Nut Allergy

Additional Details

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

Arms & Interventions

Arms

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

Interventions

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.

International Sites

Hospital for Sick Children, Toronto, Ontario, Canada

Status

Address

Hospital for Sick Children

Toronto, Ontario, M5G 1X8

Montreal Children's Hospital, Montreal, Quebec, Canada