Early Introduction and Sustained Ingestion (EISI) Using Two Educational Opportunities in Infants
Recruiting
N/AInterventional Study
Food Allergy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
4 Months – 11 Months
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
92 (estimated)
Sponsor
Stanford University · Other
Who this trial is looking for
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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.
Trial Locations
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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 (excl…
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
Contacts
No contact information available.
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