Early Introduction of Allergenic Foods in Infants With Extra Support

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This 6-month feasibility pilot randomly assigns caregiver-infant pairs to two groups: standard education versus education plus additional in-person or live-stream support. All participants receive three educational modules about early introduction and infant nutrition, with quizzes after each module. The intervention group also has supervised feeding sessions and optional clinician guidance. Outcomes focus on usability of materials and whether early allergen introduction is increased. The study is conducted at Stanford with blood draws and clinician supervision at key visits.

Why it matters

Who can join: the full rules

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

Where it's running

• Stanford University
  Stanford, California, United States Recruiting

Study contacts

• Principal investigator: Sharon Chinthrajah, MD — Stanford University

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.