Early Peanut Introduction: Translation to Clinical Practice

NCT03019328 | Completed DMC

• 2 other identifiers: IRB000958331U01AI125290
• Study Type: observational
• Target: 333
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Percent of infants with peanut allergy at baseline

  Percentage of infants who fail the peanut challenge at the baseline visit

  Baseline

Secondary Outcomes (6)

• Compare results of peanut skin prick test to peanut challenge outcomes among the high risk infants

  baseline

• Compare results of anti-peanut IgE testing to peanut challenge outcomes among the high risk infants

  baseline

• Compare results of anti-Ara h2 IgE testing to peanut challenge outcomes among the high risk infants

  baseline

• Percent of infants who develop peanut allergy by age 30 months

  30 months

• Percent of infants with a skin prick test of 3 mm or more at baseline who develop peanut allergy

  30 months

Interventions

Peanut in diet OTHER

Eligibility Criteria

• Age: 4 Months - 11 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants age 4 monhts to 11 months

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Massachusetts General Hospital: collaborator

Study Sites (2)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Bloods, skin swabs, skin tape strips

MeSH Terms

Conditions

Peanut Hypersensitivity; Dermatitis, Atopic; Eczema

Interventions

Diet

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Corinne Keet, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Robert Wood, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 12, 2017
• Study Start: December 1, 2016
• Primary Completion: October 31, 2022
• Study Completion: March 24, 2023
• Last Updated: April 11, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)