Peanut and Tree Nut Desensitization

NCT03532360 | Active Not Recruiting

• 1 other identifier: 2017-3204
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Peanut Allergy; Tree Nut Allergy

Outcome Measures

Primary Outcomes (2)

• Efficacy of desensitization in peanut/tree nut allergic patients as measured by blinded, placebo controlled oral food challenge

  Comparison of participants randomized to treatments arms who achieve peanut/tree nut desensitization compared to participants randomized to the control groups. This is measured by whether a participant is able to tolerate a total dose of 4172 mg crushed peanut or tree nut during an oral food challenge

  21 months

• Comparison of efficacy of 30 mg dose versus 300 mg dose in inducing desensitization to peanut or tree nut as measured by blinded, placebo controlled oral food challenge

  Participants in the 30 mg arm will be compared to those in the 300 mg in terms of dose tolerated at post-immunotherapy blinded, placebo-controlled oral food challenge, as well as side effects experienced during immunotherapy

  21 months

Secondary Outcomes (6)

• Change from baseline over the immunotherapy process of peanut or tree nut (as appropriate) specigic IgE levels

  21 months

• Change from baseline over the immunotherapy process of peanut or tree nut (as appropriate) specigic IgA levels

  21 months

• Change from baseline over the immunotherapy process of peanut or tree nut (as appropriate) specigic IgG4 levels

  21 months

• Change from baseline over the immunotherapy process of mast cell activation as measured by CD63 expression

  21 months

• Change from baseline over the immunotherapy process of of DNA methylation levels

  21 months

Study Arms (3)

Control

NO INTERVENTION

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

Low-dose

ACTIVE COMPARATOR

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

Other: Oral immunotherapy

High-dose

ACTIVE COMPARATOR

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

Interventions

Oral immunotherapy OTHER

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

High-dose; Low-dose

Eligibility Criteria

• Age: 2 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 .

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Julia Upton, Hospital for Sick Children, University of Toronto: collaborator

Study Sites (2)

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Montreal Children's Hospital

Montreal, Quebec, H4A 3J1, Canada

Location

MeSH Terms

Conditions

Peanut Hypersensitivity; Nut Hypersensitivity

Interventions

Immunotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be randomized to one of three groups: a control group that will receive no treatment, a low-dose group and a high dose group. Participants in the latter two groups will be blinded as to what group they have been assigned
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Clinician

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: March 16, 2018
• First Posted: May 22, 2018
• Study Start: February 19, 2018
• Primary Completion: June 26, 2024
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 6, 2025

Record last verified: 2025-02

Locations

CA (2)