Oral immunotherapy
OtherStarting from a very low level and over a period of several months, participants receive escalating doses of the food to which they are allergic
NCT Number: NCT03532360
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
This study is active but is not currently recruiting participants.
2 year–40 year
All sexes
Interventional
Not applicable
Hospital for Sick Children, Toronto, Ontario, Canada
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients between 2 and 40 years of age who satisfy all the following criteria will be included:
Exclusion criteria
.
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
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
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
Time frame: 21 months
Measurement of peanut or tree nut (as appropriate) specific IgE before, during and after the desensitization process
Time frame: 21 months
Measurement of peanut or tree nut (as appropriate) specific IgA before, during and after the desensitization process
Time frame: 21 months
Measurement of peanut or tree nut (as appropriate) specific IgG4 before, during and after the desensitization process
Time frame: 21 months
Measurement of mast cell activation as measured by CD63 expression before, during and after the desensitization process
Time frame: 21 months
Measurement of DNA methylation levels before, during and after the desensitization process
Time frame: 21 months
Measurement of Regulatory T cell levels, before, during and after the desensitization process
McGill University Health Centre/Research Institute of the McGill University Health Centre
Other
Peanut/Tree Nut Desensitization and Induction of Tolerance in Children
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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