STEP-IT-UP - Peanut Allergy Study for Infants
STEP-IT-UP - Peanut Allergy Study for Infants
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.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 100 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Subthreshold Peanut in Infants - Understanding Plasticity
Estimated Study Start Date: November 1, 2021
Estimated Primary Completion Date: November 1, 2026
Estimated Study Completion Date: November 1, 2028
Arm:
- Active Comparator: Dietary Peanut
- No Intervention: Strict avoidance
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 100 |
| Estimated Study start date | 01 November 2021 |
| Estimated Study Completion Date | 01 November 2028 |