Peanut and Tree Nut Desensitization

NCT ID: NCT03532360

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-19
• Study Completion Date: 2027-12-31

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

Detailed Description

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

Conditions

Peanut Allergy; Tree Nut Allergy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: ACTIVE_COMPARATOR

Oral immunotherapy

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Oral immunotherapy

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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 .

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Julia Upton, Hospital for Sick Children, University of Toronto

UNKNOWN

Sponsor Role: collaborator

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Moshe Ben-Shoshan

Research Clinician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital for Sick Children

Toronto, Ontario, Canada

Montreal Children's Hospital

Montreal, Quebec, Canada

Countries

Canada

References

Upton JEM, Rivero DT, Ke D, Berenjy A, Lejtenyi D, Beaudette L, Yin X, Li CH, Duan LY, Cohen C, Kim V, Marzouk S, Grunebaum E, McCusker CT, Mazer B, Eiwegger T, Ben-Shoshan M. Peanut oral immunotherapy using 30 mg and 300 mg maintenance doses. J Allergy Clin Immunol Pract. 2025 Oct 16:S2213-2198(25)00958-4. doi: 10.1016/j.jaip.2025.10.007. Online ahead of print.

Reference Type: DERIVED

PMID: 41109568 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2017-3204

Identifier Type: -

Identifier Source: org_study_id