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Early Peanut Introduction: Translation to Clinical Practice (EPI)

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ClinicalTrials.gov Identifier: NCT03019328
Recruitment Status : Recruiting
First Posted : January 12, 2017
Last Update Posted : September 29, 2017
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Johns Hopkins University

Brief 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.

Condition or disease Intervention/treatment
Peanut Allergy Other: Peanut in diet

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
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Peanut Introduction: Translation to Clinical Practice
Study Start Date : December 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
U.S. FDA Resources




Primary Outcome Measures :
  1. Percent of infants with peanut allergy at baseline [ Time Frame: Baseline ]
    Percentage of infants who fail the peanut challenge at the baseline visit


Secondary Outcome Measures :
  1. 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

  2. Compare results of anti-peanut IgE testing to peanut challenge outcomes among the high risk infants [ Time Frame: baseline ]
    Results of anti-peanut IgE testing compared to peanut challenge among the high risk infants

  3. Compare results of anti-Ara h2 IgE testing to peanut challenge outcomes among the high risk infants [ Time Frame: baseline ]
    Results of anti-Ara h2 IgE testing compared to peanut challenge among the high risk infants

  4. Percent of infants who develop peanut allergy by age 30 months [ Time Frame: 30 months ]
    Percent of infants at risk who develop peanut allergy during the study window (30 months)

  5. Percent of infants with a skin prick test of 3 mm or more at baseline who develop peanut allergy [ Time Frame: 30 months ]
    Percent of infants with a positive skin prick test who develop peanut allergy during the study window (30 months)

  6. Peanut levels in bedroom dust as measured by home dust collection [ Time Frame: 18 months ]
    Peanut levels will be tested by Elisa in bed dust collected by patients using a DUSTREAM(R) vacuum adaptor.



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Ages Eligible for Study:   4 Months to 11 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03019328


Contacts
Contact: Daria Szelag, CRNP 410-502-4198 earlypeanutstudy@jhmi.edu
Contact: Mihaela Paradis 410-614-1555 earlypeanutstudy@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Corinne Keet, MD    410-502-4198    earlypeanutstudy@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Corinne Keet, MD Johns Hopkins University

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03019328     History of Changes
Other Study ID Numbers: IRB00095833
1U01AI125290 ( U.S. NIH Grant/Contract )
First Posted: January 12, 2017    Key Record Dates
Last Update Posted: September 29, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Johns Hopkins University:
peanut allergy
food allergens
atopic dermatitis
eczema
infant food allergy testing
skin prick testing
peanut IgE
early peanut introduction
food allergy prevention

Additional relevant MeSH terms:
Hypersensitivity
Peanut Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate