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

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT07321522
Status
Not Yet Recruiting

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Conditions

  • Food Allergy

Eligibility Criteria

Sex
ALL
Age
4 Months - 11 Months
Healthy Volunteers
Accepted

Interventions

  • Educational Sessions and Opportunities on Early Introduction and Sustained Ingestion — BEHAVIORAL
    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.
  • In person feeding session — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Jan 31, 2028
Completion
Feb 29, 2028

Study Design

Enrollment
92 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • No Intervention: Standard of Care
    The participants will be provided with three sets of educational materials to learn about early introduction of food allergens.
  • Experimental: Enhanced Educational Opportunities
    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.

Primary Outcome Measure

Compare the infant age at which allergenic foods were introduced [ Time Frame: Baseline up to six months. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94305-

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Stanford University· Stanford, CA

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