Food Allergy, Peanut Allergy
Conditions
Keywords
infant food allergy, treatment study, peanut allergy treatment, increase threshold of peanut intake for peanut allergic children
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.
Interventions
BIOLOGICALPeanut powder or peanut butter
Commercially available peanut powder or peanut butter.
Sponsors
Icahn School of Medicine at Mount Sinai
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open label, randomized trial (1:1) to either dietary peanut intake or strict avoidance prior to a double blind placebo controlled food challenge 52 weeks later.
Eligibility
Sex/Gender
ALL
Age
4 Months to 14 Months
Healthy volunteers
No
Inclusion criteria
* Children age 4-14 months suspected to be peanut allergic
Exclusion criteria
* Significant medical problems
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| Peanut skin prick test wheal size | 104 weeks | Average wheal size (millimeters) of peanut skin prick test for participants in each group. |
| Rate of discontinuation of dietary peanut | 104 weeks | Number of participants randomized to dietary peanut who discontinue peanut. |
Outcome results
None listed