RecruitingNot Applicable

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

United States92 participantsStarted 2026-06-30

Plain-language 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.

Who can participate

Age range

4 Months – 11 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria for both Infant and Caregiver/Parent Participants * 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 Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Compare the infant age at which allergenic foods were introduced

Timeframe: Baseline up to six months.

Compare the allergenic food intake frequency.

Timeframe: At the start of intervention and month 1, month 2, month 3, month 4, and month 6.

Trial details

NCT IDNCT07321522

SponsorStanford University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-01

View on ClinicalTrials.gov More Food Allergy trials