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Early Peanut Introduction: Translation to Clinical Practice

NCT03019328 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 333

Last updated 2023-04-11

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Peanut in diet

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Massachusetts General Hospital

    collaborator OTHER

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Corinne Keet, MD · Johns Hopkins University

  • Robert Wood, MD · Johns Hopkins University

Eligibility

Min Age
4 Months
Max Age
11 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2022-10-31
Completion
2023-03-24

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03019328 on ClinicalTrials.gov