Clinical trial NCT03019328: Early Peanut Introduction: Translation to Clinical Practice
Official title: Early Peanut Introduction: Translation to Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peanut Allergy
Keywords: peanut allergy
food allergens
atopic dermatitis
eczema
infant food allergy testing
skin prick testing
peanut IgE
early peanut introduction
food allergy prevention
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Massachusetts General Hospital
First posted: 2017-01-12
Enrollment: 333
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants age 4 monhts to 11 months

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.

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.

Eligibility 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

Primary outcomes:
measure: Percent of infants with peanut allergy at baseline
timeFrame: Baseline
Secondary outcomes:
measure: Compare results of peanut skin prick test to peanut challenge outcomes among the high risk infants
timeFrame: baseline
measure: Compare results of anti-peanut IgE testing to peanut challenge outcomes among the high risk infants
timeFrame: baseline
measure: Compare results of anti-Ara h2 IgE testing to peanut challenge outcomes among the high risk infants
timeFrame: baseline
measure: Percent of infants who develop peanut allergy by age 30 months
timeFrame: 30 months
measure: Percent of infants with a skin prick test of 3 mm or more at baseline who develop peanut allergy
timeFrame: 30 months
measure: Peanut levels in bedroom dust as measured by home dust collection
timeFrame: 18 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Johns Hopkins University
name: Corinne Keet, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Robert Wood, MD
role: PRINCIPAL_INVESTIGATOR
References: