STEP-IT-UP - Peanut Allergy Study for Infants

Food Allergy Clinical Trial

Official title:

Subthreshold Peanut in Infants - Understanding Plasticity

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04761835
• Other study ID #: IRB00279285
• Status: Withdrawn
• Phase: Phase 2
• Start date: November 1, 2021
• Est. completion date: November 1, 2028

Study information

• Verified date: March 2021
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 1, 2028
• Est. primary completion date: November 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Months to 14 Months

Eligibility

Inclusion Criteria:

• Children age 4-14 months suspected to be peanut allergic

Exclusion Criteria:

• Significant medical problems

Related Conditions & MeSH terms

• Food Allergy
• Food Hypersensitivity
• Hypersensitivity
• Peanut Allergy
• Peanut Hypersensitivity

Intervention

Biological:
• Peanut powder or peanut butter
Commercially available peanut powder or peanut butter.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Icahn School of Medicine at Mount Sinai

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	52 weeks
Secondary	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.	104 weeks
Secondary	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.	56 weeks
Secondary	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.	60 weeks
Secondary	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.	52 weeks
Secondary	Rate of discontinuation of dietary peanut	Number of participants randomized to dietary peanut who discontinue peanut.	104 weeks
Secondary	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.	104 weeks
Secondary	Peanut skin prick test wheal size	Average wheal size (millimeters) of peanut skin prick test for participants in each group.	104 weeks