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STEP-IT-UP - Peanut Allergy Study for Infants

NCT ID: NCT04761835

Last Updated: 2021-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2028-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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Peanut Allergy Food Allergy

Keywords

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infant food allergy treatment study peanut allergy treatment increase threshold of peanut intake for peanut allergic children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dietary Peanut

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.

Group Type ACTIVE_COMPARATOR

Peanut powder or peanut butter

Intervention Type BIOLOGICAL

Commercially available peanut powder or peanut butter.

Strict avoidance

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Peanut powder or peanut butter

Commercially available peanut powder or peanut butter.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Significant medical problems
Minimum Eligible Age

4 Months

Maximum Eligible Age

14 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Corinne Keet

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Other Identifiers

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IRB00279285

Identifier Type: -

Identifier Source: org_study_id