Educational Support for Food Allergy Prevention

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Food allergy, Tube-fed, Developmental delay, Severe eczema, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

The objective of the study is to see whether early feeding of potentially allergic foods can be increased with educational materials alone or with educational materials and additional in-person support opportunities. This study will help guide what types of support pediatricians and allergists give to new parents.

Who Is on the Research Team?

Sharon Chinthrajah, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for parents or caregivers over 18 with infants born at term (37-41 weeks gestation), regardless of family history of allergies or presence of mild to moderate eczema. Infants must not have started consuming T9 foods, except cow's milk/soy in formula, and agree to two blood draws during the 6-month study.

Inclusion Criteria

Both my child and I meet the study's requirements.

I was born at full term.

My infant may or may not have a family history of allergies.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive educational materials and, for the intervention group, additional in-person or live-stream video support and in-clinic feedings

6 months

3 visits (in-person or virtual) for intervention group

Follow-up

Participants are monitored for allergenic food intake and questionnaire completion

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Early Introduction and Sustained Ingestion (EISI)

Trial Overview

The trial examines if educational materials alone or combined with in-person support can increase early feeding of allergy-risk foods. It aims to inform pediatricians and allergists on supporting new parents in preventing food allergies.

How Is the Trial Designed?

Group I: Enhanced Educational Opportunities Experimental Treatment 2 Interventions

The participants will be provided with three sets of educational materials to learn about early introduction of food allergens, as well as 3 in-person monthly teaching sessions (up to 3 months), lasting 30 minutes to enhance the information and allow for questions. This arm will also have one to two in-clinic feedings of any of the top 9 most allergenic foods. The oral feeding portion will add an additional 1 to 2 hours at the one of the 3 visits.

Group II: Standard of Care Active Control 1 Intervention

The participants will be provided with three sets of educational materials to learn about early introduction of food allergens.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+