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Peanut and Tree Nut Desensitization

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ClinicalTrials.gov Identifier: NCT03532360
Recruitment Status : Recruiting
First Posted : May 22, 2018
Last Update Posted : September 11, 2019
Sponsor:
Collaborator:
Julia Upton, Hospital for Sick Children, University of Toronto
Information provided by (Responsible Party):
Bruce Mazer, McGill University Health Centre/Research Institute of the McGill University Health Centre

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

Condition or disease Intervention/treatment Phase
Peanut Allergy Tree Nut Allergy Other: Oral immunotherapy Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: Single (Participant)
Masking Description: 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
Primary Purpose: Treatment
Official Title: Peanut/Tree Nut Desensitization and Induction of Tolerance in Children
Actual Study Start Date : February 19, 2018
Estimated Primary Completion Date : January 2, 2024
Estimated Study Completion Date : January 2, 2024

Arm Intervention/treatment
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
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

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




Primary Outcome Measures :
  1. Efficacy of desensitization in peanut/tree nut allergic patients as measured by blinded, placebo controlled oral food challenge [ Time Frame: 21 months ]
    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

  2. 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 [ Time Frame: 21 months ]
    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


Secondary Outcome Measures :
  1. Change from baseline over the immunotherapy process of peanut or tree nut (as appropriate) specigic IgE levels [ Time Frame: 21 months ]
    Measurement of peanut or tree nut (as appropriate) specigic IgE before, during and after the desensitization process

  2. Change from baseline over the immunotherapy process of peanut or tree nut (as appropriate) specigic IgA levels [ Time Frame: 21 months ]
    Measurement of peanut or tree nut (as appropriate) specigic IgA before, during and after the desensitization process

  3. Change from baseline over the immunotherapy process of peanut or tree nut (as appropriate) specigic IgG4 levels [ Time Frame: 21 months ]
    Measurement of peanut or tree nut (as appropriate) specigic IgG4 before, during and after the desensitization process

  4. Change from baseline over the immunotherapy process of mast cell activation as measured by CD63 expression [ Time Frame: 21 months ]
    Measurement of mast cell activation as measured by CD63 expression before, during and after the desensitization process

  5. Change from baseline over the immunotherapy process of of DNA methylation levels [ Time Frame: 21 months ]
    Measurement of DNA methylation levels before, during and after the desensitization process

  6. Change from baseline over the immunotherapy process of Regulatory T cell levels [ Time Frame: 21 months ]
    Measurement of Regulatory T cell levels, before, during and after the desensitization process



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria: Children 6 years and older 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 .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03532360


Contacts
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Contact: Duncan Lejtenyi, MSc 514-934-1934 ext 22369 duncan.lejtenyi@muhc.mcgill.ca
Contact: Jennifer Lee 514-934-1934 ext 67096 jennifer.lee@muhc.mcgill.ca

Locations
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Canada, Ontario
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Alireza Berenjy    (416) 813-7654 ext 202897    alireza.berenjy@sickkids.ca   
Principal Investigator: Julia Upton, MD         
Canada, Quebec
Montreal Children's Hospital Recruiting
Montreal, Quebec, Canada, H4A 3J1
Contact: Duncan Lejtenyi, MSc    514-934-1934 ext 22369    duncan.lejtenyi@muhc.mcgill.ca   
Contact: Jennifer Lee    514-934-1934 ext 67096    jennifer.lee@muhc.mcgill.ca   
Principal Investigator: Moshe Ben-Shoshan, MD         
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
Julia Upton, Hospital for Sick Children, University of Toronto
  Study Documents (Full-Text)

Documents provided by Bruce Mazer, McGill University Health Centre/Research Institute of the McGill University Health Centre:
Study Protocol  [PDF] August 7, 2019
Informed Consent Form  [PDF] August 1, 2019


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Responsible Party: Bruce Mazer, Executive Director and CSO (Interim), McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT03532360     History of Changes
Other Study ID Numbers: 2017-3204
First Posted: May 22, 2018    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypersensitivity
Peanut Hypersensitivity
Nut Hypersensitivity
Immune System Diseases
Nut and Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate