- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03019328
Early Peanut Introduction: Translation to Clinical Practice (EPI)
April 10, 2023 updated by: Johns Hopkins University
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.
Study Overview
Detailed Description
400 infants aged 4-11 months from three high risk groups will be enrolled in a prospective observational study.
All subjects will have a baseline research clinic visit, where they will be given a peanut skin prick test, peanut food challenge and have blood drawn for measurement of peanut immunoglobulin E (IgE).
Based on the baseline oral food challenge, the participants will be advised to begin introducing peanut following the current practice guidelines.
Participants will then be followed until 30 months of age with two clinic visits and regular monitoring of peanut consumption.
Study Type
Observational
Enrollment (Actual)
333
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins Hospital
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 months to 11 months (Child)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Infants age 4 monhts to 11 months
Description
Inclusion Criteria:
- Infants age 4-11 months
Have at least one of the following criteria:
- physician diagnosis of milk, egg or other non-peanut food allergy,
- 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".
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of infants with peanut allergy at baseline
Time Frame: Baseline
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Percentage of infants who fail the peanut challenge at the baseline visit
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compare results of peanut skin prick test to peanut challenge outcomes among the high risk infants
Time Frame: baseline
|
Results of peanut skin prick tests compared to peanut challenge among the high risk infants
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baseline
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Compare results of anti-peanut IgE testing to peanut challenge outcomes among the high risk infants
Time Frame: baseline
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Results of anti-peanut IgE testing compared to peanut challenge among the high risk infants
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baseline
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Compare results of anti-Ara h2 IgE testing to peanut challenge outcomes among the high risk infants
Time Frame: baseline
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Results of anti-Ara h2 IgE testing compared to peanut challenge among the high risk infants
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baseline
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Percent of infants who develop peanut allergy by age 30 months
Time Frame: 30 months
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Percent of infants at risk who develop peanut allergy during the study window (30 months)
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30 months
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Percent of infants with a skin prick test of 3 mm or more at baseline who develop peanut allergy
Time Frame: 30 months
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Percent of infants with a positive skin prick test who develop peanut allergy during the study window (30 months)
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30 months
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Peanut levels in bedroom dust as measured by home dust collection
Time Frame: 18 months
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Peanut levels will be tested by Elisa in bed dust collected by patients using a DUSTREAM(R) vacuum adaptor.
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18 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Corinne Keet, MD, Johns Hopkins University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2016
Primary Completion (Actual)
October 31, 2022
Study Completion (Actual)
March 24, 2023
Study Registration Dates
First Submitted
January 10, 2017
First Submitted That Met QC Criteria
January 10, 2017
First Posted (Estimate)
January 12, 2017
Study Record Updates
Last Update Posted (Actual)
April 11, 2023
Last Update Submitted That Met QC Criteria
April 10, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00095833
- 1U01AI125290 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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