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RECRUITING
NCT07321522
NA

Early Introduction and Sustained Ingestion (EISI) Using Two Educational Opportunities in Infants

Sponsor: Stanford University

View on ClinicalTrials.gov

Summary

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.

Official title: Early Introduction and Sustained Ingestion (EISI) Using Two Educational Opportunities - A Pilot Study

Key Details

Gender

All

Age Range

4 Months - 11 Months

Study Type

INTERVENTIONAL

Enrollment

92

Start Date

2026-06-30

Completion Date

2028-02

Last Updated

2026-06-26

Healthy Volunteers

Yes

Conditions

Interventions

BEHAVIORAL

Education and Opportunities on Early Introduction

The participant will receive and review three educational modules on the basics of food allergy, food allergy reactions, food allergen introduction, feeding safety and readiness, fiber, fermented food, ultra processed foods, diet diversity, and advancing food textures in the infant diet. The educational sessions will take approximately one hour to review every month for three months.

BEHAVIORAL

Clinician Supervised Feeding of Known Allergenic Food

Clinician supervised feeding introduction of a known allergenic food (hen's egg, cow's milk, peanut, tree nuts, soy, wheat, fin fish, shellfish, and sesame) to the infant at least one time during the 6 month enrollment. The feeding is required for the intervention group and optional for the standard-of-care (SOC) group. Participants in the SOC group who do not introduce any known allergenic foods at home into the infant's diet by the end of 3 months enrollment will be required to return to the clinic for a clinician supervised feeding of a known allergenic food of their choice. The clinic feeding will last approximately 1 hour.

Locations (1)

Stanford University

Stanford, California, United States