NCT03019328

Early Peanut Introduction: Translation to Clinical Practice

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 333 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 4 Months – 11 Months
• Healthy volunteers: Accepted

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.

Conditions

• Peanut Allergy

Interventions

Type	Name	Description
OTHER	Peanut in diet

Timeline

• Start date: 2016-12-01
• Primary completion: 2022-10-31
• Completion: 2023-03-24
• First posted: 2017-01-12
• Last updated: 2023-04-11

Locations

2 sites across 1 country: United States