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Clinical Trial Details for Early Peanut Introduction: Translation to Clinical Practice


Johns Hopkins University
NCT ID: NCT03019328
Last Updated: September 13, 2019

The Study at a Glance

  • Status: Recruiting
  • Phase:
  • Gender: All
  • Age: 4 Months - 11 Months
  • Condition: Peanut Allergy
  • Study Type: Observational
  • Intervention:
  • Lead Sponsor: Johns Hopkins University
  • Location: Not Provided

Official Title

Early Peanut Introduction: Translation to Clinical Practice

Purpose

The recent finding that early introduction of peanut can prevent ~70-90% of peanut allergy is a major step towards prevention of food allergy. However, because that finding was from a clinical trial in a very select population, there are several major questions that must be answered in order to implement these findings into clinical practice without causing more harm than good. These questions include who, if anyone, should be screened prior to early introduction for peanut allergy, how this screening should be done, and what quantity of peanut ingestion is needed to prevent peanut allergy. The goal of this project is to answer these critical questions so that the potential of these recent findings can be realized. To that end, 400 infants at high-risk of peanut allergy will be enrolled. These infants will be given a peanut skin prick test, peanut food challenge and have blood drawn for measurement of peanut IgE, and then will be followed for assessment of peanut consumption and development of peanut allergy until 3 years of age.

Eligibility

Ages Eligible for Study

4 Months to 11 Months

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Study Population

Infants age 4 monhts to 11 months

Criteria

Inclusion Criteria:

– Infants age 4-11 months

– Have at least one of the following criteria:

1. physician diagnosis of milk, egg or other non-peanut food allergy,

2. at least moderate eczema as defined by a SCORAD score of at least 25 on present
or previous evaluation, OR a rash that required the application of topical creams
or ointments containing corticosteroids or calcineurin inhibitors and occurred on
at least 7 days on two separate occasions, or is described by the parent or
guardian as "a bad rash in joints or creases" or "a bad itchy, dry, oozing or
crusted rash".

3. a first degree relative (parents or siblings) with either a physician diagnosis
of IgE mediated peanut allergy OR reported history of symptoms consistent with
IgE mediated peanut allergy (onset of symptoms within 2 hours of exposure, AND
symptoms of urticaria, angioedema, wheezing, vomiting, or abdominal pain with
exposure, AND no subsequent exposure to peanut without symptoms).

Exclusion Criteria:

– History of feeding problems

– History of eosinophilic gastro-intestinal disease

– Significant medical history (aside from eczema, food allergy or history of wheeze)

– History of peanut reactions or tolerance prior to baseline screening

Additional Information, Locations & Contacts

Sponsors & Collaborators

Johns Hopkins University

National Institute of Allergy and Infectious Diseases (NIAID)

Massachusetts General Hospital

Investigators

Principal Investigator: Corinne Keet, MD

Johns Hopkins University

Please refer to this study by its ClinicalTrials.gov identifier: NCT03019328

Location

Contacts

Johns Hopkins Hospital

Baltimore, Maryland 21287

United States

Corinne Keet, MD

earlypeanutstudy@jhmi.edu

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Cynthia Esteban, NP

foodallergy@mgh.harvard.edu