Early Introduction and Sustained Ingestion (EISI) Using Two Educational Opportunities in Infants
Early Introduction and Sustained Ingestion (EISI) Using Two Educational Opportunities - A Pilot Study
Stanford University
92 participants
Jun 30, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- Born term (37 weeks - 41 weeks gestation)
- Infants with or without a family history of allergic disease
- Infants with or without mild to moderate eczema
- Infants who have not yet started consuming known allergenic foods (excluding cow's milk or soy if it is in their infant formula)
- Parent or caregiver ≥ 18 years of age
- Agree to infant blood draw (two)
- Agree to participate in the 6 month research study
Exclusion Criteria6
- Infants with a physician confirmed food allergy
- Infants who do not eat fully by an oral route such as tube-fed or tube-supplemented babies
- Infants with developmental delay
- Infants with severe eczema
- Infants who are already consuming known allergenic foods
- Infants participating in another study looking at diet, oral immunotherapy or the use of a biological agent
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Interventions
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.
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)
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NCT07321522