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

NCT07321522 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2026-05-05

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Educational Sessions and Opportunities on Early Introduction and Sustained Ingestion

The participant will attend three in person sessions on the basics of food allergy, food allergy reactions, feeding safety and readiness, fiber, ultra processed foods, diet diversity, and advancing food textures in the infant diet. The educational sessions will last 20 - 30 minutes every month for three months.

BEHAVIORAL

In person feeding session

Participants will attend an in-person feeding of a known top 9 food allergen (hen's egg, cow's milk, peanut, tree nuts, soy, wheat, fin fish, shellfish, and sesame) to the infant at least one time, and up to two times. The clinic feeding will last 1 - 2 hours.

Sponsors & Collaborators

Principal Investigators

  • Sharon Chinthrajah, MD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Months
Max Age
11 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2028-01-31
Completion
2028-02-29

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07321522 on ClinicalTrials.gov