The purpose of this study is to determine if walnut oral immunotherapy can be used in subjects allergic to tree nuts to decrease their tree nut allergy and induce changes in their immune system.
Tree nut
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Daily ingestion of gradually increasing amounts of walnut protein flour in order to induce desensitization to walnut and an unrelated tree nut.
Oat flour that is administered as a placebo in identical increasing doses as the active walnut flour treatment.
Effectiveness of walnut oral immunotherapy (WOIT) on clinical desensitization to a second tree nut.
The determination of the effectiveness of WOIT in inducing clinical desensitization to a second tree nut to which the subject is allergic when compared to placebo. This will be measured by the change in the amount of tree nut the subject can consume during their food challenge at 38 weeks compared to their consumption during the baseline challenge at study entry.
Time frame: 38 weeks
Percentage of subjects who can tolerate a 5000mg oral food challenge to walnut protein following the desensitization phase of the study
The percentage of subjects who can consume all of the 5000mg of walnut protein without symptoms during the food challenge after the desensitization phase of the study.
Time frame: 38 weeks
The percentage of subjects who are able to reach a cumulative protein dose of 2000mg at the desensitization oral food challenge to walnut and the test tree nut.
The percentage of subjects who are able to consume a cumulative protein dose of 2000 mg of walnut and test tree nut without symptoms during the desensitization oral food challenge.
Time frame: 38 weeks
The percentage of subjects who demonstrate clinical tolerance at the end of the study to walnut and the test tree nut.
The percentage of subjects who are able to demonstrate clinical tolerance by consuming all of the walnut and test tree nut without symptoms during the oral food challenge at the end of the study.
Time frame: 36 months
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