STEP-IT-UP - Peanut Allergy Study for Infants
- Conditions
- Peanut AllergyFood Allergy
- Interventions
- Biological: Peanut powder or peanut butter
- Registration Number
- NCT04761835
- Lead Sponsor
- Johns Hopkins University
- Brief Summary
Multicenter randomized (1:1) trial of strict avoidance versus sub-threshold dietary introduction of peanut in peanut allergic infants 4-14 months of age who react at a minimum cumulative dose of at least 430 mg of peanut protein at initial oral food challenge (OFC) for 12 months, followed by cross-over to sub-threshold dietary introduction of peanut in those randomized initially to avoidance.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Children age 4-14 months suspected to be peanut allergic
- Significant medical problems
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dietary Peanut Peanut powder or peanut butter Participants in this group will be asked to continue peanut in their diet for 1 year at a dose determined from the double blind placebo controlled food challenge at baseline. After the 1 year period, participants will be given another double blind placebo controlled food challenge which will be used to determine their current peanut threshold. The current peanut threshold will be used to determine which participants will go into clinical care and which will get sustained unresponsiveness food challenges to peanut.
- Primary Outcome Measures
Name Time Method Oral food challenge threshold to peanut at week 52 52 weeks compare the oral food challenge threshold (in milligrams) to peanut during a double-blind placebo-controlled food challenge (DBPCFC) after 12 months between subjects randomized to dietary peanut introduction and those randomized to avoidance.
- Secondary Outcome Measures
Name Time Method Rate of discontinuation of dietary peanut 104 weeks Number of participants randomized to dietary peanut who discontinue peanut.
Peanut skin prick test wheal size 104 weeks Average wheal size (millimeters) of peanut skin prick test for participants in each group.
Severity of eczema as assessed by the Scoring Atopic Dermatitis (SCORAD) score 104 weeks Eczema severity as assessed by the SCORAD. The SCORAD has a component for patient measured outcomes and also provider assessment of eczema involvement. It has an overall score range of 0-100, where higher scores signify more severe eczema.
1. Oral food challenge threshold to peanut at week 52 for those initially randomized to dietary peanut compared to the oral food challenge threshold at week 104 for those initially randomized to strict avoidance 104 weeks Compare the oral food challenge threshold (in milligrams) to peanut during a double-blind placebo-controlled food challenge (DBPCFC) after 12 months of dietary peanut between subjects randomized to dietary peanut introduction first and those randomized to avoidance for 52 weeks and subsequent dietary peanut after week 52.
Oral food challenge threshold at 1 month avoidance after 12 months in each treatment group 56 weeks Comparison of OFC threshold (in milligrams) at 1 month of avoidance (sustained unresponsiveness) after 12 months of dietary peanut between those initially randomized to peanut and those randomized to delayed introduction.
Oral food challenge threshold at 2 months avoidance after 12 months in each treatment group 60 weeks Comparison of OFC threshold (in milligrams) at 2 months of avoidance (sustained unresponsiveness) after 12 months of dietary peanut between those initially randomized to peanut and those randomized to delayed introduction.
Safety with dietary introduction of peanut or avoidance 52 weeks Number of participants who have severe (grade 3) anaphylaxis secondary to any DBPCFC or ingestion of the measured dose of peanut.