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Recruiting
NCT07321522
Early Introduction and Sustained Ingestion (EISI) Using Two Educational Opportunities in Infants
Conditions: Food Allergy
Sex: All
Ages: 4 Months – 11 Months
Healthy volunteers: Yes
Phase: NA
Enrollment: 92
Sponsor: Stanford University
Location: Stanford University Stanford California
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 Criteria
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
Source: ClinicalTrials.gov (NCT07321522). StuddyBuddy aggregates publicly available trial information.