Early Peanut Introduction: Translation to Clinical Practice (EPI)

• ClinicalTrials.gov Identifier: NCT03019328
• Recruitment Status: Active, not recruiting
• First Posted: January 12, 2017
• Last Update Posted: November 8, 2022
• Sponsor: Johns Hopkins University
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); Massachusetts General Hospital
• Information provided by (Responsible Party): Johns Hopkins University

Study Description

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 Design

• Study Type: Observational
• Estimated Enrollment: 400 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Early Peanut Introduction: Translation to Clinical Practice
• Actual Study Start Date: December 2016
• Actual Primary Completion Date: October 31, 2022
• Estimated Study Completion Date: April 30, 2023

Groups and Cohorts

Outcome Measures

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.

Biospecimen Retention:   Samples With DNA

Bloods, skin swabs, skin tape strips

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, Maryland

Johns Hopkins Hospital

Baltimore, Maryland, United States, 21287

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Johns Hopkins University

National Institute of Allergy and Infectious Diseases (NIAID)

Massachusetts General Hospital

Investigators

• Principal Investigator: Corinne Keet, MD; Johns Hopkins University

More Information

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT03019328
• Other Study ID Numbers: IRB00095833; 1U01AI125290 ( U.S. NIH Grant/Contract )
• First Posted: January 12, 2017
• Last Update Posted: November 8, 2022
• Last Verified: October 2022

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; Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate