A Phase 2 interventional study of Peanut powder or peanut butter in Peanut Allergy and Food Allergy, sponsored by Johns Hopkins University. Withdrawn. Open to participants aged 4 Months to 14 Months. Per ClinicalTrials.gov, last updated 2021-11-17.
Sponsored by Johns Hopkins University · Phase 2, Interventional, and Treatment
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.
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Exclusion Criteria:
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.
Biological: Peanut powder or peanut butter
Participants in this group will be asked to strictly avoid any peanut in their diet for 1 year. After the 1 year period, participants will be given another double blind placebo controlled food challenge which will be used to determine whether they will transition to daily dietary peanut or continue with clinical care.
Commercially available peanut powder or peanut butter.
Oral food challenge threshold to peanut at week 52
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.
Time frame: 52 weeks
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
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.
Time frame: 104 weeks
Oral food challenge threshold at 1 month avoidance after 12 months in each treatment group
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.
Time frame: 56 weeks
Oral food challenge threshold at 2 months avoidance after 12 months in each treatment group
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.
Time frame: 60 weeks
Safety with dietary introduction of peanut or avoidance
Number of participants who have severe (grade 3) anaphylaxis secondary to any DBPCFC or ingestion of the measured dose of peanut.
Time frame: 52 weeks
Rate of discontinuation of dietary peanut
Number of participants randomized to dietary peanut who discontinue peanut.
Time frame: 104 weeks
Severity of eczema as assessed by the Scoring Atopic Dermatitis (SCORAD) score
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.
Time frame: 104 weeks
Peanut skin prick test wheal size
Average wheal size (millimeters) of peanut skin prick test for participants in each group.
Time frame: 104 weeks
No study locations are listed for this record.
Plan to share: No — No individual participant level data will be shared. Only aggregate data from the study will be shared.
No publications or documents are linked to this record.
This study is withdrawn, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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