At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Challenging to Food With Escalating Thresholds for Reducing Food Allergy
In Brief
A Phase 2 clinical trial evaluating Peanut Protein and Continued peanut avoidance for Food Allergy and Peanut Allergy. Completed, enrolled 73 participants across 1 site.
Detailed Summary
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 Details
Timeline
Interventions
up to 3 level teaspoons peanut butter or equivalent (approximately 3400 mg)
Standard of care avoidance of peanut