The primary objective of this study is to determine whether allowing ingestion of sub-threshold amounts of peanut in those with a high threshold (tolerate at least 143 mg peanut protein on supervised double-blind, placebo-controlled oral food challenge \[DBPCFC\]) will be associated with attaining even higher thresholds over time in children with high threshold peanut allergy compared to those avoiding peanut. The secondary clinical objectives include assessing the development of sustained unresponsiveness (SU, a surrogate term for tolerance without daily ingestion), effects on quality of life, and safety compared to those avoiding peanut. Additionally, this study will phenotype the allergic response to peanut based on threshold and response to exposure. Mechanistic study objectives will determine the immune and molecular basis of the high threshold endotype, identify predictors of response to exposure, and determine mechanisms and biomarkers of remission.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
73
up to 3 level teaspoons peanut butter or equivalent (approximately 3400 mg)
Standard of care avoidance of peanut
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Percentage of Children That Tolerate the Full Challenge
The difference between the treatment and comparison (avoidance) groups in the percentage of children who by the endpoint double-blind, placebo-controlled oral food challenge (DBPCFC) tolerate a dose at least 2 steps higher than their baseline DBPCFC or 9043 mg of peanut protein. Due to missing data in the primary endpoint, the protocol \& SAP specified a priori that missing data would be imputed using multiple imputation and results based on 30 completed-imputed data sets would be combined using Rubin's rule. In the Peanut Protein group, the observed data was so strong that participants with missing data were also imputed as success across all imputations (hence, 100% success rate). In the Peanut Avoidance group, there was more variability in the proportion of successes across imputations and these varying proportions were averaged. Missing data were imputed and results were pooled.
Time frame: 72 weeks
The Percentage of Children That Achieve Sustained Unresponsiveness
The percentage of children who achieve sustained unresponsiveness or natural tolerance during the study.
Time frame: 96 weeks
Number of Children With Acute Allergic Reactions
Safety parameter assessed by number of participants with acute allergic reactions which includes anaphylaxis or gastrointestinal side effects.
Time frame: 96 weeks
Mean Change in Food Allergy Quality of Life Parental Burden Instrument
The Food Allergy Quality of Life-Parental Burden (FAQL-PB) Scale is a 17-item instrument. It utilizes a 7-point Likert scale ranging from 0 (not troubled) to 6 (extremely troubled). The number circled for each question is summed to provide a total continuous score range of 0 to 102 with a higher score indicating greater burden on the family.
Time frame: baseline and at 72 weeks
Mean Change in SPT Wheal Size
Change in Skin Prick Test (SPT) mean wheal size at 72 weeks as compared to baseline. A skin test reaction is considered positive if the wheal size for the antigen is at least 3 mm larger than the wheal size of the negative control (saline).
Time frame: Baseline and 72 weeks
Mean Change in Peanut-specific IgE
Mean Change in Peanut-specific IgE level at week 72 as compared to baseline.
Time frame: Baseline and 72 weeks
Mean Change in Peanut-specific IgG4
Mean Change in Peanut-specific IgG4 level at week 72 as compared to baseline.
Time frame: Baseline and 72 weeks
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