STEP-IT-UP - Peanut Allergy Study for Infants

Johns Hopkins University

Status and phase: Withdrawn; Phase 2

Conditions: Food Allergy; Peanut Allergy

Treatments: Biological: Peanut powder or peanut butter

Study type: Interventional

Funder types: Other

Identifiers

NCT04761835

IRB00279285

Details and patient eligibility

About

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.

Sex: All

Ages: 4 to 14 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Significant medical problems

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Dietary Peanut

Active Comparator group

Description:

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.

Treatment:

Biological: Peanut powder or peanut butter

Strict avoidance

No Intervention group

Description:

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.